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How Does the FDA Approve a Drug?
 
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Have you ever taken an over the counter medication for heartburn? How about an antibiotic for an ear infection? At some point pretty much all of us have visited a pharmacy to pick up a drug, but likely didn't consider where these drugs come from or how they are made. Whether you're talking about something for seasonal allergies or your grandparent's arthritis medication, the act of bringing a drug to market is long and complex. I'm not an expert, but HCT intern Rachel Hoffman is, and with her help, that's the topic of this week's Healthcare Triage. For those of you who want to read more, go here: http://theincidentaleconomist.com/wordpress/?p=63822 John Green -- Executive Producer Stan Muller -- Director, Producer Aaron Carroll -- Writer Mark Olsen -- Graphics http://www.twitter.com/aaronecarroll http://www.twitter.com/crashcoursestan http://www.twitter.com/johngreen http://www.twitter.com/olsenvideo And the housekeeping: 1) You can support Healthcare Triage on Patreon: http://vid.io/xqXr Every little bit helps make the show better! 2) Check out our Facebook page: http://goo.gl/LnOq5z 3) We still have merchandise available at http://www.hctmerch.com
Views: 54107 Healthcare Triage
How Does The FDA Approve New Drugs?
 
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How Powerful Is Russia? http://bit.ly/1Ov9jE1 » Subscribe to NowThis World: http://go.nowth.is/World_Subscribe For decades, Cuba's been under an embargo, but its relations with the U.S. are now easing. So how powerful is the communist nation? Learn More: Castro steps down as Cuban leader http://news.bbc.co.uk/2/hi/americas/7252109.stm "Cuba's ailing leader Fidel Castro has announced he will not accept another term as president, ending the communist revolutionary's 49 years in power." Anuario Estadistico de Cuba http://www.one.cu/aec2014/07%20Empleo%20y%20Salarios.pdf El presente capítulo tiene como objetivo mostrar la evolución de indicadores relacionados con el empleo, los salarios, la protección del trabajo, la seguridad social y la asistencia social. Cuban Immigrants in the United States http://www.migrationpolicy.org/article/cuban-immigrants-united-states "Cuba has occupied a unique place in U.S. immigration law and policy as a result of fraught political relations and geographic proximity between the two countries." US-Cuba agree commercial flights deal http://www.bbc.com/news/world-us-canada-35117319 "The United States and Cuba have agreed to restore regular commercial flights, in a deal that could jumpstart economic relations between the two countries." Music Track Courtesy of APM Music: "Concentration" _________________________ NowThis World is dedicated to bringing you topical explainers about the world around you. Each week we’ll be exploring current stories in international news, by examining the facts, providing historical context, and outlining the key players involved. We’ll also highlight powerful countries, ideologies, influential leaders, and ongoing global conflicts that are shaping the current landscape of the international community across the globe today. More from NowThis: » Tweet @NowThisNews on Twitter: http://go.nowth.is/News_Twitter » Subscribe to NowThis News: http://go.nowth.is/News_Subscribe » Like NowThis World on Facebook: https://go.nowth.is/World_Facebook » Connect with Judah: Follow @judah_robinson on Twitter – Facebook: http://go.nowth.is/LikeJudah » Connect with Versha: Follow @versharma on Twitter – Facebook: http://go.nowth.is/LikeVersha http://www.youtube.com/nowthisworld Special thanks to Aneeta Akhurst for hosting TestTube!
Views: 81607 NowThis World
The FDA Drug Development Process: GLP, GMP and GCP Regulations
 
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This Video provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations. This Video is ideal for those who are new to the Drug Development process and those experienced researchers that need an update on FDA requirements. This webinar will address the basic Drug Development Process, nonclinical trials and human clinical trials. In addition the two major FDA submissions during Drug Development will be covered - the IND submission and the NDA submission. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: support@globalcompliancepanel.com Help us caption & translate this video! http://amara.org/v/JGhy/
Views: 21187 GlobalCompliance Panel
FDA Gives Approval To First Generic EpiPen
 
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The U.S. Food and Drug Administration on Thursday announced the approval of the first generic version of EpiPen.
Views: 47 CBS Pittsburgh
5 Things You Need to Know About the Drug Approval Process
 
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This hand drawn white board video illustrates the 5 important stages of drug approval by the FDA. Discovery and Screening, IND Application Submission, Clinical Trials, Application Review and Inspections, and Safety Monitoring.
Views: 6867 USFoodandDrugAdmin
FDA Drug Approval Process Trailer
 
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This web seminar provides an overview of what is required to take a new drug from research to market. We will begin by reviewing the contents of an IND, and then follow the process of an IND submission. From there, the contents and approval process of an NDA submission will be discussed. This web seminar will also provide a foundation for those who require an understanding of the FDA new drug approval process, and help attendees become familiar with the regulatory landscape in which INDs and NDAs are developed and approved.
Views: 2011 Kathy Barnett
U.S. FDA Self-Identification Requirements for Generic Drugs
 
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Between May 1 and June 1 of each year, operators of facilities that produce generic drugs and generic drug active pharmaceutical ingredients (APIs) must submit self-identification information to FDA. FDA uses this information to determine which user fees a facility is subject to under the Generic Drug User Fee Amendments (GDUFA). Fiscal Year (FY) 2018 introduced numerous changes to GDUFA, including new contract manufacturing organization facility fees, abbreviated new drug application (ANDA) program fees, and more. Registrar Corp's webinar covers the self-identification process and recent developments under GDUFA, concluding with a live Question & Answer session.
Views: 67 Registrar Corp
Generic drug maker skipped steps required for FDA approval
 
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A Ranbaxy whistleblower uncovered disturbing problems with the data required by the FDA to prove the effectiveness of drugs. Dinesh Thakur found that the company received approval to sell drugs that were based on no data or data that was fraudulent. John Miller reports.
Views: 1782 CBS Evening News
New Drugs approved by FDA in MARCH 2018
 
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New drugs approved in March 2018 Trogarzo Injection Generic Name: ibalizumab-uiyk Dosage Form: Injection Company: TaiMed Biologics USA Corp. Date of Approval: March 6, 2018 Treatment for: HIV Infection Company: TaiMed Biologics USA Corp. Ibalizumab (trade name Trogarzo) is a non-immunosuppressive monoclonal antibody that binds CD4, the primary receptor for HIV, and inhibits the viral entry process. It is being investigated as an HIV entry inhibitor with the ability to block both CCR5- and CXCR4-tropic viruses. Ilumya Generic Name: tildrakizumab-asmn Dosage Form: Injection, for Subcutaneous Use Company: Sun Pharmaceutical Industries Inc. Date of Approval: March 20, 2018 Treatment for: Plaque Psoriasis Ilumya (tildrakizumab-asmn) is a humanized, anti-IL-23p19 monoclonal antibody for the treatment of moderate-to-severe plaque psoriasis. Please subscribe the channel “Pharma Digest”; Please like and share video Music: https://www.bensound.com
Views: 863 Pharma Digest
New Drug Approved by FDA in July - 2017
 
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New Drug Approvals in July- 2017 1. Vosevi (Sofosbuvir, Velpatasvir and Voxilaprevir) Tablets Company: Gilead Sciences, Inc. Treatment for: Chronic Hepatitis C 2. Nerlynx (Neratinib) Tablets Company: Puma Biotechnology, Inc. Treatment for: Breast Cancer -- Adjuvant 3. Tremfya (Guselkumab) Injection Company. Janssen Biotech, Inc. Treatment for: Plaque Psoriasis 4. Endari (L-glutamine) Oral Powder Company: Emmaus Life Sciences Inc. Treatment for: Sickle Cell Anemia Subscribe the channel “Pharma Digest” for information related to pharma and medical field. Like and share the video. Music credits: https://www.bensound.com
Views: 1406 Pharma Digest
FDA approves generic EpiPen
 
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The FDA has approved the first generic rival to EpiPen. The self-injecting device used to treat potentially life-threatening allergic reactions has faced a number of issues in recent years, including shortages and notoriously high prices. The new generic copy will be sold by Teva Pharmaceuticals. Anna Werner reports. Subscribe to the "CBS This Morning" Channel HERE: http://bit.ly/1Q0v2hE Watch "CBS This Morning" HERE: http://bit.ly/1T88yAR Watch the latest installment of "Note to Self," only on "CBS This Morning," HERE: http://cbsn.ws/1Sh8XlB Follow "CBS This Morning" on Instagram HERE: http://bit.ly/1Q7NGnY Like "CBS This Morning" on Facebook HERE: http://on.fb.me/1LhtdvI Follow "CBS This Morning" on Twitter HERE: http://bit.ly/1Xj5W3p Follow "CBS This Morning" on Google+ HERE: http://bit.ly/1SIM4I8 Get the latest news and best in original reporting from CBS News delivered to your inbox. Subscribe to newsletters HERE: http://cbsn.ws/1RqHw7T Get your news on the go! Download CBS News mobile apps HERE: http://cbsn.ws/1Xb1WC8 Get new episodes of shows you love across devices the next day, stream local news live, and watch full seasons of CBS fan favorites anytime, anywhere with CBS All Access. Try it free! http://bit.ly/1OQA29B Delivered by Norah O’Donnell and Gayle King, "CBS This Morning" offers a thoughtful, substantive and insightful source of news and information to a daily audience of 3 million viewers. The Emmy Award-winning broadcast presents a mix of daily news, coverage of developing stories of national and global significance, and interviews with leading figures in politics, business and entertainment. Check local listings for "CBS This Morning" broadcast times.
Views: 1856 CBS This Morning
First generic EpiPen gets FDA approval
 
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ᐸpᐳThe US Food and Drug Administration has approved the first generic competitor to EpiPen and EpiPen Jr. for the emergency treatment of allergic reactions in adults and children.ᐸ/pᐳ
Views: 15 KCTV5 News
Alexander Questions Califf on Generic Drug Approval Wait Times, FDA Use of Guidance
 
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At today’s HELP Committee hearing on the nomination of Dr. Robert Califf to head the Food and Drug Administration (FDA), Chairman Alexander questioned Califf on why the backlog for generic drug approvals has increased—despite the FDA receiving about 1 billion in new funds over the last three years. Alexander also asked for assurance Califf would look into the FDA’s issuing of guidance instead of going through the rulemaking process.
Views: 129 HELPCommitteeGOP
FDA Drug Approval Process Trailer
 
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This web seminar provides an overview of what is required to take a new drug from research to market. We will begin by reviewing the contents of an IND, and then follow the process of an IND submission. From there, the contents and approval process of an NDA submission will be discussed. This web seminar will also provide a foundation for those who require an understanding of the FDA new drug approval process, and help attendees become familiar with the regulatory landscape in which INDs and NDAs are developed and approved.
Views: 230 Kathy Barnett
PEPFAR -- Tentative approval
 
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This video captures the criteria necessary for becoming an FDA-approved generic drug that can be used in the President's Emergency Plan for AIDS Relief program. It highlights the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research’s role in using the concept of tentative approval to make generic drugs available in PEPFAR countries. The video closes with a list of the tentatively approved, PEPFAR generic drugs. http://www.fda.gov/drugs/resourcesforyou/specialfeatures/ucm312754.htm [vpdrugs]
Views: 544 USFoodandDrugAdmin
FDA on target to approve record number of generic drugs
 
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Commissioner Scott Gottlieb details move that could lower cost of prescription medicine for millions on 'Journal Editorial Report'
Views: 2048 Fox News
The FDA Finally Approves Generic EpiPen That May Be Cheaper | TIME
 
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The FDA just approved a generic EpiPen manufactured by Teva Pharmaceuticals. Subscribe to TIME ►► http://po.st/SubscribeTIME Get closer to the world of entertainment and celebrity news as TIME gives you access and insight on the people who make what you watch, read and share. https://www.youtube.com/playlist?list=PL2EFFA5DB900C633F Money helps you learn how to spend and invest your money. Find advice and guidance you can count on from how to negotiate, how to save and everything in between. https://www.youtube.com/playlist?list=PLYOGLpQQfhNKdqS_Wccs94rMHiajrRr4W Find out more about the latest developments in science and technology as TIME’s access brings you to the ideas and people changing our world. https://www.youtube.com/playlist?list=PLYOGLpQQfhNIzsgcwqhT6ctKOfHfyuaL3 Let TIME show you everything you need to know about drones, autonomous cars, smart devices and the latest inventions which are shaping industries and our way of living https://www.youtube.com/playlist?list=PL2862F811BE8F5623 Stay up to date on breaking news from around the world through TIME’s trusted reporting, insight and access https://www.youtube.com/playlist?list=PLYOGLpQQfhNJeIsW3A2d5Bs22Wc3PHma6 CONNECT WITH TIME Web: http://time.com/ Twitter: https://twitter.com/TIME Facebook: https://www.facebook.com/time Google+: https://plus.google.com/+TIME/videos Instagram: https://www.instagram.com/time/?hl=en Magazine: http://time.com/magazine/ Newsletter: time.com/newsletter ABOUT TIME TIME brings unparalleled insight, access and authority to the news. A 24/7 news publication with nearly a century of experience, TIME’s coverage shapes how we understand our world. Subscribe for daily news, interviews, science, technology, politics, health, entertainment, and business updates, as well as exclusive videos from TIME’s Person of the Year, TIME 100 and more created by TIME’s acclaimed writers, producers and editors. The FDA Finally Approves Generic EpiPen That May Be Cheaper | TIME https://www.youtube.com/user/TimeMagazine
Views: 1618 TIME
FDA Approval: Drug Development (Part I)
 
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Curious about discovering opportunity in pharma development pipelines. In this first of a 2-part series, investor-pharma scientist Hugh McManus shares an overview of the FDA process as we prepare to examine the path taken by the obesity solutions pursued by Arena Pharma (ARNA) and Vivus (VVUS).
Views: 9212 Manifest Investing
Contrave New FDA Approved Diet Pill: Is It For You?
 
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http://www.richardlipmanmd.com. Contrave is the third new FDA approved weight loss medication released in the past 2 years. Contrave is a combination of two generic drugs—bupropion (trade name Wellbutrin, on the market since 1985) and naltrexone (trade name ReVia, on the market since 1995). These two medications have few weight loss effects when used individually, but when combined in an extended release form, they act synergistically in the hypothalamus of the brain to reduce hunger, stop cravings, and increase metabolism. Physicians have prescribed the two components of Contrave individually for numerous medical problems for many years without any significant side effects or complications. Bupropion has been used for depression, anxiety, and cigarette smoking, and naltrexone for alcohol and drug addiction. Neither medication has shown significant weight loss effects when taken alone. Contrave has the least side effects of all of the new medications. Side effects include nausea, constipation and headache and usually disappear. There is no insomnia, jitteryness, anxiety and racy feeling seen in most diet pills. More than 60% of patients lose more than 10% of their weight with Contrave as compared to placebo. Read more at http"//www.richardlipmanmd.com
Views: 6057 richard Lipman
Generic Drugs: Learn about the Lifecycle from Brand Name Prescriptions to Generics
 
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Ever wonder why generic drugs cost $4 at some pharmacies? Generic drugs are the final stage in a long lifecycle that starts with innovator biopharmaceutical research companies researching and developing brand prescription medicines. This video highlights the stops & starts, successes & failures that often result in low-cost options for many people. Keep in mind as you watch that only 2 out of 10 drugs approved by the FDA will ever earn revenues that exceed average R&D costs. Help others understand the story behind the prescription drug lifecycle by sharing this video.
Views: 44930 PhRMAPress
FDA Drug Info Rounds, July 2012: Patents and Exclusivity
 
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Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition. [vpdrugs]
Views: 8560 USFoodandDrugAdmin
FDA approves Mylan generic MS treatment
 
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The FDA approved Mylan's generic version of Teva's blockbuster multiple sclerosis drug. Meg Tirrell reports why this could be the first of more drug approvals to come.
Views: 251 NBRbizrpt
FDA Regulatory Affairs Webinar - Asphalion
 
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The latest US drug regulation news a solid introduction into FDA Regulatory Affairs by Reguliance and Asphalion. REGULIANCE is a regulatory consulting firm focused on US FDA-related pharmaceutical and biopharmaceutical development and commercialization. Founded in 2002, Reguliance provides an array of services including: FDA regulatory insight, strategy, and support, to small- and medium-size domestic and foreign companies. http://reguliance.com/ ASPHALION is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona and Munich. We offer comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies. http://www.asphalion.com/ Topics & mapping: 1. Welcome & Introduction of REGULIANCE and ASPHALION and their services - 0:00:00 h 2. FDA and What’s Hot - 0:03:30 h a. General introduction to FDA b. Announcement and implications of the new 2018 NDA and ANDA User Fees (PDUFA VI and GDUFA II) c. Establishment Registration Requirements d. FDA Foreign Inspection Program 3. Obligations and Regulatory Options during Drug Development - 0:25:00 h a. Meetings with FDA b. IND Application c. US Agent Requirements d. DMF 4. Drug Registration in the US - Pathways and Dossiers a. NDA 505(b)(1) and 505(b)(2) - 1:26:00 h b. BLA c. ANDA 5. eCTD Latest Requirements - 2:08:30 h a. Dates and Deadlines b. Strategy for Compliance 6. Questions (via Chat) and Answers 2:15:40 h
Views: 487 Asphalion SL
Webinar : Hot Topics in Generic Drug Entry and Regulation
 
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Hot Topics in Generic Drug Entry and Regulation -- Examining Recent Trends in Citizens Petitions , "Pay for Delay " Settlements and Strategies for Navigating the Delicate Intersection of IP and Regulatory Law Presented by Chad A. Landmon Partner Axinn, Veltrop & Harkrider LLP Examining the causes and effects of the recent uptick in citizens petitions Understanding the ever-changing review requirements Obtaining approval in light of pending citizens petitions Strategies for obtaining court review of petition decisions Update on the current status of recent trends in "pay-for-delay" settlements and the fallout from FTC v. Actavis Chad Landmon is a partner at Axinn, Veltrop & Harkrider LLP, where he chairs the FDA Practice Group and co-chairs the IP Group. Mr. Landmon has extensive experience in food and drug law and patent litigation and counseling. His patent litigation practice is national in scope and concentrates on the life sciences industry. Mr. Landmon maintains a particular focus on Paragraph IV litigation. Mr. Landmon provides counseling and litigation services relating to patent, FDA and antitrust issues involving the development and marketing of new and generic drug products. He has litigated a wide variety of Paragraph IV cases in numerous jurisdictions, including cases involving blockbuster drugs. His FDA matters involve petitioning FDA and litigating issues relating to the Hatch-Waxman Act, including marketing exclusivities, patent listing, certification and notification requirements, bioequivalence, labeling and other issues relevant to the FDA drug approval process. Mr. Landmon's practice also includes matters involving the intersection of the antitrust and patent laws, such as issues arising from the settlement of patent and Hatch-Waxman exclusivity disputes. Mr. Landmon frequently speaks and writes about issues relating to the Hatch-Waxman Act and pharmaceutical patent litigation.hatch
Views: 1668 Matt Godson
Quicker Generic Drug Approvals Should Mean Lower Drug Prices
 
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Quicker Generic Drug Approvals Should Mean Lower Drug Prices The FDA set a record last year for the number of approvals for new generic drugs. But, the experts add, even more can be done to get generics on pharmacy shelves and keep drug prices coming down. Holley noted that studies have shown some drug prices dropping as much as 80 percent when generics enter the marketplace. Generics were also being approved more quickly last year. Quicker approvals By comparison, more than 90 percent of nongeneric drug applications typically win approval in the first cycle, Dr. Kathleen Uhl the director of the FDA's Office of Generic Drugs, said last spring. Those first-cycle approvals have been rising since 2012, she said, and a Drug Competition Action Plan announced in May was supposed to further ramp up approval of generics. There's only so much the FDA can do, however. Getting Congress to act The bill "could fulfill some of the promises made during the State of the Union on reducing drug prices," Holley said. Generics are likely to be an increasingly large portion of the drug market no matter what happens.
Views: 4 Gnews Health
Alexander Questions FDA Witness Dr. Janet Woodcock on Backlog of Generic Drug Approvals
 
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Chairman Alexander questions Director at the Center for Drug Evaluation and Research at FDA Dr. Janet Woodcock on why the median approval time of generic drugs has slowed from 30 to 48 months despite an extra $1 billion in funding.
Views: 353 HELPCommitteeGOP
FDA Approves Generic Version of EpiPen Injectors
 
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For the first time, the Federal Food and Drug Administration has approved a generic auto-injector for epinephrine, promising cheaper medicine costs for consumers. CBS2's Dr. Max Gomez reports.
Views: 230 CBS New York
At Last, FDA Approves Generic EpiPen
 
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A life-saving but increasingly costly treatment for severe allergic attacks is about to get cheaper. Gizmodo reports the FDA has approved a generic version of the EpiPen and EpiPen Jr. The approval comes in the wake of scandals involving manufacturer Mylan's version. One such scandal includes an ongoing shortage of the drug epinephrine. Epinephrine rapidly halts the symptoms of a life-threatening allergic reaction. The EpiPen is an auto-injectable device that administers the hormone. https://gizmodo.com/fda-finally-approves-a-cheaper-generic-version-of-the-1828400920 http://www.wochit.com This video was produced by YT Wochit News using http://wochit.com
Views: 34 Wochit News
Biosimilar Generic Biologics In The USA Approval Pathway
 
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This video presents an overview of FDA's requirements for approval/marketing of a Biosimilar (Generic Biologic) product. The webinar covers the Biosimilar product testing requirements (clinical and nonclinical) and the Biosimilar approval pathway. The video also reviews the Regulatory/Scientific/Quality principles involved along with the 3 FDA Biosimilar guideline documents. In addition, the FDA Stepwise Approach and the FDA Totality of the Evidence concepts will be discuss. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: support@globalcompliancepanel.com Help us caption & translate this video! http://amara.org/v/JGYo/
Sun Pharma Gets US FDA Approval For Zetia Generic
 
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Sun Pharma gets US FDA approval for Zetia generic. Ekta Batra gets us more details.
Views: 102 CNBC-TV18
FDA Wants To Help Generic Drug Makers Make It To Market
 
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The FDA is taking two strides towards lowering the cost prescription drug alternatives and increasing competition. Known as the Drug Competition Action Plan, the initiative began last month according to the agency. So far, the Food and Drug Administration has published a list of off-patent, off-exclusivity branded drugs without approved generics. However, the agency also implemented a new policy to expedite the review of generic drug applications when market-competition is limited. The FDA plans to continue this specific policy until three newly approved generic drugs are available on the market. http://www.upi.com/Health_News/2017/06/28/FDA-takes-steps-in-increase-availability-of-generic-versions-of-medications/3741498669517/ http://www.wochit.com This video was produced by YT Wochit Vote It using http://wochit.com
Views: 26 Wochit Politics
The impact of the FDA's approval of the first 'biosimilar' drug
 
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On Friday, the FDA approved a "biosimilar" version of the cancer drug Neupogen. CBS News chief medical correspondent Dr. Jon LaPook explains how the new technique could lower the enormous cost of expensive drugs.
Views: 1137 CBS Evening News
FDA Approves Generic EpiPen
 
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According to UPI, the FDA approved the first generic EpiPen. The Food and Drug Administration's decision will allow Teva Pharmaceuticals to manufacture standard auto-injectors for children and adults. FDA Commissioner Scott Gottlieb stated that the decision is part of the agency's commitment for generic options of critically important medicines. Although the EpiPen is an auto-injector device, it contains epinephrine that is used to treat severe allergic reactions. Although other brands and generic options for epinephrine-loaded auto-injectors are available, the market was been cornered by drug maker Mylan. https://www.upi.com/Health_News/2018/08/16/FDA-approves-first-generic-EpiPen/9731534439063/ http://www.wochit.com This video was produced by YT Wochit Vote It using http://wochit.com
Views: 12 Wochit Politics
FDA Publicly Accuses Drug Companies Of Trying To Block Generic Meds
 
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According to a report by Gizmodo, the United States' Food and Drug Administration published a list of pharmaceutical companies that it accuses of impeding the development of generic drugs. The list, released on Thursday, include big names like Novartis, GlaxoSmithKline, Pfizer, and Valeant Pharmaceuticals that it accuses of putting in place obstacles that delay the development of generic medications. The list was published following President Donald Trump's statement at a White House press conference last week, where he pledged to lower prescription drug costs. He claimed that “foreign, developed nations” are getting a “free-ride by setting drug prices at unfairly low levels, leaving American patients to pay for the innovation that foreign patients enjoy.” https://gizmodo.com/fda-publicly-shames-drug-companies-that-block-generic-m-1826074736 http://www.wochit.com This video was produced by YT Wochit News using http://wochit.com
Views: 109 Wochit News
United States Generic Drugs Market to be USD 210 Billion by 2024
 
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For more Info: https://www.renub.com/united-states-generic-drugs-market-nd.php As per Renub Research analysis United States Generic Drugs Market is anticipated to be more than USD 210 Billion by the year 2024. It has approximately 80% share of total dispensing prescriptions. Now most of the physicians and hospitals like prescribe generic drugs as compared to branded drugs. What is a Generic Drug? It is a Pharmaceutical drug that has the same chemical composition as patented drug. It has the same Active Pharmaceutical Ingredient (API) as original, but may have different manufacturing process, excipients, color, taste and packaging. It is only allowed when the patent(s) of on original drug is expired. Request a free sample copy of the report: https://www.renub.com/contactus.php Generic Drugs Market in United States In 2007, the Food and Drug Administration (FDA) launched the Generic Initiative for Value and Efficiency (GIVE) to increase the number and a variety of generic products by modernizing and streamlining approval process for generic drugs in US. For making a generic drug, pharmaceutical companies are required to file an Abbreviated New Drug Application with FDA. Why Generic Drugs are more affordable than Branded Drugs? A branded drug has to go through many phases before coming into the market; initial phase is drug discovery, target identification and validation then Primary Screening, Secondary Screening, Lead Optimization, Pre-Clinical Animal Studies and various other tests. As new drug development is a complex process and involves various R & D of chemicals, but clinical trials and regulatory processes are also required to be approved for human use of drugs. How Drugs Development Process Works? According to some studies only 5 out of 5000 preclinical drugs are tested on the human for medical use out of those 5 drugs only 1 is approved by FDA. There are various stages involved in drug development. Drug Discovery and Target Validation: In this stage drug development company chooses a molecule, such as a protein or gene and test it with a drug. After testing multiple drugs only a few are selected for next stage. Preclinical Testing: It is divided into subcomponents: in vitro and in vivo testing. In vitro testing examines drug molecules interactions in test tubes in the lab setting. In vivo testing involves test is being done on animal models and other living cell cultures. These tests may take several years before going to next stage. Investigational New Drug Application Filing: At this stage an application is submitted to FDA before beginning human clinical trials. At this point FDA will scrutinize the outcomes of preclinical testing, side effects and other safety measures for an experimental drug. When IND got approved by FDA then it can move onto human trials. After IND approval a patented drugs' 20 year exclusivity period begins. Client can Purchase this Report in Sections from below link: Access full Research: https://www.renub.com/united-states-off-label-drugs-market-and-forecast-51-p.php Phase 1 Clinical Studies: At this stage testing involves a small group of healthy people from a dozen to a few in numbers and safety is taken as a primary concern. Now all the side effect of drug, how a drug is absorbed & elimination from the body is tested. Phase 2 Clinical Studies: After getting positive outcomes from Phase1, Phase 2 begins in this phase the number of patients grows from a few dozen to 100 or more patients who are suffering from disease. Safety is also a big concern at this point and short term side effects are also monitored closely. Phase 3 Clinical Studies: At this stage the number of patients for drug testing grow from a few hundred to thousands. It is the longest and costliest of all components of development process. New Drug Application Filing: At this point application is filed to FDA, with all the research and safety data of initial stages having tens of thousands to 100,000 or more pages. After getting affirmation from FDA, Prescription Drug User Fee Act (PDUFA) date is set 10 months. PDUFA Date and Decision: FDA will wait for PDUFA date for its decision. FDA has 3 choices: it can approve a drug, it can deny a drug or it can request additional information by sending a Complete Response Later (CRL). If a drug is approved by FDA, now it becomes immediately available for commercial production. Phase 4 Clinical Studies: After 8 steps an approved drug can used for medical purpose, but it doesn't mean it is not under scrutiny of FDA, FDA can request long-term safety measures, side effect and adverse effect of drug.
Views: 4 Renub Research
Unmet needs in regulatory science for generic drugs
 
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Robert Lionberger, Ph.D., Director of the Office of Research and Standards in the Office of Generic Drugs (OGD) at the FDA describes regulatory science initiatives of OGD and unmet needs for generic drugs.
Views: 608 Stanford
🎓 Study examines expedited FDA drug approvals, safety questions remain
 
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Study examines expedited FDA drug approvals, safety questions remain ** Watch in HD** -The expedited drugs were tested for efficacy in a median 104 patients compared with a median 580 patients for standard review. By 2013, many postmarketing studies to gather additional evidence on the safety of expedited drugs had not been completed, according to researchers. AMA Intern Med. Published online October 28, 2013. doi:10.1001/jamainternmed.2013.11813 - http://healthresearchreport.me/2013/11/01/study-examines-expedited-fda-drug-approvals-safety-questions-remain-avg-drug-is-tested-on-only-104-patients-prior-to-approval/
Views: 102 VHFILM
FDA Head Says Agency Will Take Action to Lower Drug Prices
 
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On Oct. 2, FDA Commissioner Scott Gottlieb announced a series of steps to speed up the regulatory approvals of certain kinds of generic alternatives to pricey “complex” drugs.
FDA Approved High Number of New Drugs in 2015
 
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The Food and Drug Administration approved 45 drugs in 2015, and all new drugs included never-before-sold ingredients
The FDA and the Pharmaceutical Industry
 
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Carpenter, author of Reputation and Power:Organizational Image and Pharmaceutical Regulation at the FDA will join us to discuss the FDA and the pharmaceutical industry. The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Carpenter traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints. Sponsored by the USC Bedrosian Center as part of it's on-going Governance Salons. Daniel Carpenter is Allie S. Freed Professor of Government and Director of the Center for American Political Studies in the Faculty of Arts and Sciences at Harvard University. For the 2011-2012 academic year, he is a Walter Channing Cabot Faculty Fellow at Harvard, and a visiting researcher at the Institut d'Études Politiques at the Université de Strasbourg in France. He graduated from Georgetown University in 1989 with distinction in Honors Government and received his doctorate in political science from the University of Chicago in 1996. He taught previously at Princeton University (1995-1998) and the University of Michigan (1998-2002). He joined the Harvard University faculty in 2002. Dr. Carpenter mixes theoretical, historical, statistical and mathematical analyses to examine the development of political institutions, particularly in the United States. He focuses upon public bureaucracies and government regulation, particularly regulation of health and financial products. His dissertation received the 1998 Harold D. Lasswell Award from the American Political Science Association and as a book - The Forging of Bureaucratic Autonomy: Reputations, Networks and Policy Innovation in Executive Agencies, 1862-1928 (Princeton: Princeton University Press, 2001) - was awarded the APSA's Gladys Kammerer Prize as well as the Charles Levine Prize of the International Political Science Association. His recently published book on pharmaceutical regulation in the United States is entitled Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton: Princeton University Press, 2010), and has received the 2011 Allan Sharlin Memorial Award from the Social Science History Association. Professor Carpenter has held fellowships from the John Simon Guggenheim Foundation, the Radcliffe Institute for Advanced Study, the Center for Advanced Study in the Behavioral Sciences, the Brookings Institution and the Santa Fe Institute. He has received grants from the National Endowment for the Humanities, the National Science Foundation, the Robert Wood Johnson Foundation (Scholars in Health Policy 1998-2000, Investigator Award in Health Policy Research 2004-2007), the Alfred Sloan Foundation, the Russell Sage Foundation and the Safra Center for Ethics. In the past few years, Professor Carpenter is the winner of both the 2011 Herbert Simon Award of the Midwest Political Science Association for a scholar "who has made a significant career contribution to the scientific study of bureaucracy", as well as the 2011 David Collier Award of the American Political Science Association for career contributions to qualitative and multi-method research. In addition to his ongoing teaching and scholarship on the political economy of government regulation and health, Professor Carpenter has recently launched a long-term project on petitioning in North American political development, examining comparisons and connections to petitioning histories in Europe and India. He hopes to draw upon the millions of petitions in local, state and federal archives to create an educational, genealogical and scholarly resource for citizens, students and scholars.
Views: 37788 USC Price
Are all medications FDA approved, even those from overseas?
 
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Maya - a mailmyprescriptions.com licensed pharmacist - shares how all prescribed medications and OTC drugs must be FDA-approved. Mailmyprescriptions.com is America’s first mail-order pharmacy to offer direct-from-the-wholesaler, guaranteed low pricing on FDA-approved generic drugs. For more information on how you can save on your generic prescription drugs, visit https://goo.gl/NNAoeA Subscribe for more updates, news, and videos. STAY CONNECTED: Facebook: https://www.facebook.com/mailmyprescriptions/ Instagram: https://www.instagram.com/mailmyprescriptions/ Twitter: https://twitter.com/mailmyrx LinkedIn: https://www.linkedin.com/company/mailmyprescriptions.com
FDA Approved: How the FDA Approval Process Works
 
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Explains the process that drug makers have to go through to receive approval from the Food and Drug Administration.
Views: 27717 All Classic Video
FDA Bans Generic Original OxyContin: New Form Of Painkiller Will Be Abuse-Resistant
 
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The Food and Drug Administration announced on Tuesday that they will not approve any generic versions of the original form of the widely abused painkiller OxyContin. In April of 2010 the FDA approved Purdue Pharma's reformulated version of the drug that is resistant to chewing, crushing, breaking, or dissolving in water. OxyContin is one of the most powerful and abused painkillers on the market. The original form can be snorted, injected, or smoked to produce a quick high. According to the Centers for Disease Control and Prevention, overdoses from painkillers in the U.S. caused more deaths in 2010 than heroin and cocaine combined. Purdue's new version was designed to discourage the painkiller's abuse, and when dissolved in water, it simply turns into jelly. When FDA approved Purdue's reformulated version of Oxycontin three years ago, they called it a "step in the right direction"... but now, in 2013, the FDA has banned the original form of the drug, barring it from the legal U.S. market. The FDA said in a statement, "The FDA has determined that the benefits of original OxyContin no longer outweigh its risks." With Purdue's exclusive patent rights to produce the original OxyContin approaching its expiration date, generic pharmaceutical firms were eyeing the opportunity to produce the potentially dangerous drug. Thumbnail credit: Flickr user 'pingpongdeath' But, sadly for them, Purdue Pharma now has many more years of exclusive patent rights over its new abuse-resistant version of Oxycontin.
Views: 1852 IBTimesTV
News Update: Hospira, Inc. Receives FDA Approval for Generic AstraZeneca Plc Drug
 
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Hospira, Inc. (NYSE:HSP) officials announced Tuesday that the company has received US Food & Drug Administration approval for Meropenem, a generic version of AstraZeneca Plc's (NYSE:AZN) Merrem I.V. Merrem I.V. by AstraZeneca is used to lower the development of drug resistance in bacteria and the company earned an estimated $200 million in sales from the drug last year. Shares of Hospira were up 0.6% earlier Tuesday, and shares of the company continue to trade up 0.16% mid-day at $56.74. Shares of AstraZeneca are also trading up 1.23% at $45.42.
Views: 642 TradeTheTrend
Epic Drug Scandal
 
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Scott Gottlieb, M.D., former Deputy Commissioner at the Food and Drug Administration (FDA) and resident fellow at the American Enterprise Institute, describes how the FDA’s narrowly prescriptive generic drug approval process creates expensive barriers to market entry that led to the EpiPen drug pricing debacle.
Food And Drug Administration Approves First Generic Version Of EpiPen | NBC Nightly News
 
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The generic of the lifesaving allergy medication will offer a cheaper alternative to the Mylan’s EpiPen, which has come under fire for massive price hikes. » Subscribe to NBC News: http://nbcnews.to/SubscribeToNBC » Watch more NBC video: http://bit.ly/MoreNBCNews NBC News is a leading source of global news and information. Here you will find clips from NBC Nightly News, Meet The Press, and original digital videos. Subscribe to our channel for news stories, technology, politics, health, entertainment, science, business, and exclusive NBC investigations. Connect with NBC News Online! Visit NBCNews.Com: http://nbcnews.to/ReadNBC Find NBC News on Facebook: http://nbcnews.to/LikeNBC Follow NBC News on Twitter: http://nbcnews.to/FollowNBC Follow NBC News on Google+: http://nbcnews.to/PlusNBC Follow NBC News on Instagram: http://nbcnews.to/InstaNBC Follow NBC News on Pinterest: http://nbcnews.to/PinNBC Food And Drug Administration Approves First Generic Version Of EpiPen | NBC Nightly News
Views: 1501 NBC News