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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: 58272 Healthcare Triage
In 2018 FDA approved highest number of generic drugs ever: Alex Azar
 
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Health & Human Services Secretary Alex Azar on the Trump administration's efforts to reduce drug prices, mounting concerns over the marketing of e-cigarettes and the surge in the FDA's approval of generic drugs.
Views: 1392 Fox Business
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: 1817 CBS Evening News
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: 23148 GlobalCompliance Panel
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: 1294 Pharma Digest
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: 2152 Fox 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
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: 7759 USFoodandDrugAdmin
Chairman Moran Conducts Hearing on FDA’s Role in Generic Drug Marketplace
 
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U.S. Senator Jerry Moran (R-Kan.), Chairman of the Senate Agriculture Appropriations Committee, presided over a hearing this week to examine the FDA’s Role in the generic drug marketplace. The hearing included testimony from U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research Director Janet Woodcock.
Views: 551 Jerry Moran
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: 57 CBS Pittsburgh
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: 46553 PhRMAPress
FDA Drug Approval Process
 
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FDA Drug Approval Process - 1992-03-20 - Product 25104-1-DVD - House Committee Government Reform and Oversight. Subcommittee on Human Resources and Intergovernmental Relations. Featuring the Commissioner of the FDA. Filmed by C-SPAN. Non-commercial use only. For more information, see http://www.c-spanvideo.org/program/25104-1
Views: 735 HouseResourceOrg
FDA's New Drug Approvals Fall to Six Year Low
 
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Turns out 2016 was a disappointing year for new drug approvals, as the United States Food and Drug Administration cleared only 22 new medicines for sale to consumers. This represents the lowest number since 2010, and is sharply down from 2015's total of 45 new drugs. The slowdown suggests the pharmaceuticals industry may be returning to a more normal productivity rate, following a spike in approvals in 2014 and 2015, when the clearance rate on new drugs introduced into the market hit a 19-year high. Despite the downward trend, most industry executives remain upbeat about the hunt for new medicines, given recent advances in fighting cancer and an improved understanding of the genetic basis of other diseases.
Views: 3 HealthFeed News
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: 103 Registrar Corp
First Generic EpiPen Gets FDA Approval
 
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First Generic EpiPen Gets FDA Approval
Views: 48 WJZ
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: 358 HELPCommitteeGOP
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: 38904 USC Price
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: 28 KCTV5 News
FDA approves Teva’s generic version of Mylan’s EpiPen
 
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AllergyKids Foundation Founder Robyn O’ Brien discusses how the FDA approved the first generic version of the EpiPen.
Views: 1163 Fox Business
Generic Drug Approval Process, Part 2
 
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Generic Drug Approval Process, Part 2 - 10918-1-DVD - House Energy and Commerce - 1989-09-11 - House Committee on Energy and Commerce. Joint Hearing with the Committee on Armed Services. Subcommittee on Oversight and Investigations. Congressional hearing on the generic drug approval process at the Food and Drug Administration. House Energy and Commerce Subcommittee on Oversight heard testimony from officials at pharmaceutical companies under investigation by the FDA. Filmed by C-SPAN. Non-commercial use only. For more information, see http://www.c-spanvideo.org/program/10918-1
Views: 106 HouseResourceOrg
ANDA vs. 505(b)(2): When and Why? Webinar
 
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In this recording of our December 21, 2011 webinar, Dr. Nick Fleischer, Vice President, The Weinberg Group, helps regulatory executives understand some of the nuances of the ANDA and 505(b)(2) regulatory pathways. If you have any questions about this webinar, or would just like to learn more about what we do, please contact us at 202.833.8077 or science@weinberggroup.com.
Views: 8076 The Weinberg Group
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: 2092 Kathy Barnett
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: 9291 Manifest Investing
US FDA's  Generic Labeling Rule
 
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US FDA’s new Generic labeling rule? How it will allow Generic Drug Companies to update their labels? The measures to be taken and the complexities to overcome; decode the complete guidance visually
Views: 345 FreyrInc
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: 286 NBRbizrpt
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/
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: 118 Wochit News
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
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: 3598 TIME
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: 8725 USFoodandDrugAdmin
Teva’s Generic EpiPen Approved by FDA Just in Time for Back-to-School
 
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Register for our free featured webinar here - https://buff.ly/2LuU65T Read more on this story here: https://buff.ly/2LrXbDG It’s been a long time coming, but US patients will finally have access to the first generic version of the EpiPen, developed by Israeli pharmaceutical company Teva. The US Food and Drug Administration (FDA) approved Teva’s generic versions of the EpiPen and EpiPen Jr and the timing couldn’t be better for patients as Mylan has been struggling to provide adequate supply of the auto-injector to pharmacies in the US and Canada. For more news stories, visit: http://xtalks.com/News Receive weekly news and webinar updates right in your inbox: https://xtalks.com/register/ Listen live and interact with featured speakers on our upcoming Life Science webinars: https://xtalks.com/life-sciences/
Views: 50 Xtalks Webinars
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: 106 CNBC-TV18
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.
The FDA Approves Generic EpiPen
 
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Reuters MYL Mylan Br 38.24 0.38 (+1.00 %) Disclaimer Get real-time MYL charts here " TEVA TevaPharmInd Sp ADR 24.17 -0.01 (0.00 %) Disclaimer Get real-time TEVA charts here " The FDA on Thursday approved Teva Pharmaceuticals' generic version of the drug, dealing a blow to branded EpiPen-maker Mylan. Mylan saw an approximately 63% drop in EpiPen sales between 2017 and 2016, according to calculations made by Wells Fargo analyst David Maris. Analysts estimate that Teva estimate that Teva could control as much as a third of the approximate $750 million EpiPen market with its generic. https://www.businessinsider.com/mylan-teva-epipen-generic-auto-injector-market-2018-8 http://www.wochit.com This video was produced by YT Wochit News using http://wochit.com
Views: 47 Wochit News
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: 1861 IBTimesTV
First-Time Generics Approved in October
 
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http://www.rxwiki.com/news-article/generic-drugs-approved-us-food-and-drug-administration-october-2015 Several generic versions of brand-name medications received US Food and Drug Administration (FDA) approval last month. The FDA regularly approves generic versions of brand-name drugs if they appear safe and effective for patients. Generics are generally less expensive than brand-name medications. "All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs," according to the FDA. "And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand-name drugs."
Views: 9 RxWikiTV
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
Ranbaxy Gets FDA Nod For Novartis Generic Pill - TOI
 
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Ranbaxy Gets FDA Nod For Novartis Generic Pill Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration (FDA) to launch a cheaper copy of Novartis AG's blood pressure pill Diovan, bolstering its outlook after a raft of regulatory bans for poor production quality at its India facilities dented investor sentiment. Subscribe to Times Of India's Youtube channel here: http://goo.gl/WgIatu Also Subscribe to Bombay Times Youtube Channel here: http://goo.gl/AdXcgU Social Media Links: Facebook : https://www.facebook.com/TimesofIndia Times Of India's Official YouTube channel is managed by Culture Machine Media Pvt Ltd.
Views: 3901 The Times of India
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: 551 USFoodandDrugAdmin
Mylan CEO on FDA-approved biosimilar, Trump's drug price plan
 
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Nearly two years after taking tremendous heat for the rising cost of EpiPens, pharmaceutical giant Mylan is making strides in the fast-growing biosimilar market. Biosimilars are drugs and devices made to be similar to already-approved products, potentially lowering the cost of treatment. Mylan won FDA approval last week for a biosimilar drug designed to help some cancer patients reduce infection risk during chemotherapy. Mylan CEO Heather Bresch joins "CBS This Morning" to explain how biosimilars could translate to patient savings, what the company learned from the EpiPen debacle, and why she applauds President Trump's plan to reduce drug costs. 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: 3745 CBS This Morning
FDA approves Teva's generic EpiPen
 
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CNBC's Meg Tirrell reports on U.S. regulators clearing the first generic competitor to Mylan's EpiPen, after a yearslong delay that many said contributed to the emergency allergy drug's rapid rise in price.
Views: 270 CNBC Television
FDA's Generic Drug Labeling Proposal: A Disturbance of the Hatch-Waxman Balance
 
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Panel discussion held at Washington Legal Foundation's (WLF) headquarters featuring Generic Pharmaceutical Association President and CEO Ralph G. Neas; American Enterprise Institute research fellow Alex Brill; and WLF Chief Counsel Richard A. Samp.
Views: 287 WashLglFndt
Top 10 DEADLIEST DRUGS APPROVED By The FDA
 
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Welcome to Top10Archive! We frequently look to them as remedies, but some are a bit more detrimental than helpful. Though legalized and distributed by healthcare professionals, some prescription drugs are racked with adverse side effects. Using data gathered from the United States' Food and Drug Administration, this installment will cover the 10 most dangerous prescription drug pills. Specifically, we'll be looking at the most toxic prescription drugs to our bodies, not the overall death count. Support us by shopping on Amazon! http://tinyurl.com/njwyzzn 10. Metoclopramide 9. Infliximab 8. Tacrolimus 7. Zoledronic Acid 6. Dexamethasone 5. Clozapine 4. Rituximab 3. Bevacizumab 2. Prednisolone 1. Cyclophosphamide Voice Over Talent: www.JimDenisonVoice.com http://www.youtube.com/user/thought2
Views: 38388 Top 10 Archive
Cultivating a vibrant U.S. market for biosimilars: A conversation with FDA’s Scott Gottlieb - Part 1
 
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On July 18, the USC-Brookings Schaeffer Initiative for Health Policy and the Hutchins Center on Fiscal & Monetary Policy at Brookings hosted Food & Drug Administration Commissioner Scott Gottlieb for a discussion of biosimilars, which have been a major focus of the FDA’s efforts to increase competition and choice for patients and the U.S. healthcare system. https://www.brookings.edu/events/u-s-market-for-biosimilars-fda-scott-gottlieb/ (transcript available) Subscribe! http://www.youtube.com/subscription_center?add_user=BrookingsInstitution Follow Brookings on social media! Facebook: http://www.Facebook.com/Brookings Twitter: http://www.twitter.com/BrookingsInst Instagram: http://www.Instagram.com/brookingsinst LinkedIn: http://www.linkedin.com/com/company/the-brookings-institution
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.
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