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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: 52088 Healthcare Triage
How Does The FDA Approve New Drugs?
 
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Is China Fueling The Drug War? http://testu.be/1GzTYHN Subscribe! http://bitly.com/1iLOHml The Food and Drug Administration is one of the world's strictest regulatory agencies. So, how do drugs get approved for use in the U.S.? Learn More: Drug Safety/Drug Approval Process http://www.fda.gov/NewsEvents/Testimony/ucm161673.htm "Modern drugs provide unmistakable and significant health benefits." House overwhelmingly passes bill to speed FDA drug approvals http://www.washingtonpost.com/blogs/wonkblog/wp/2015/07/10/house-overwhelmingly-passes-bill-to-speed-fda-drug-approvals/ "A bipartisan bill that would make significant changes to the process for developing new drugs and medical devices overwhelmingly passed the House in a 344-77 vote Friday morning." Novel New Drugs 2013 Summary http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM381803.pdf "In Calendar Year 2013, FDA's Center for Drug Evaluation and Research (CDER) approved 27 novel new medicines, known as new molecular entities (NMEs)." As drug making goes global, oversight found lacking http://www.usatoday.com/story/news/2012/10/21/global-drug-manufacturing-oversight/1646487/ "The medicines you took this morning could have come from anywhere, and everywhere, in the world." Subscribe to TestTube Daily! http://bitly.com/1iLOHml _________________________ TestTube News is committed to answering the smart, inquisitive questions we have about life, society, politics and anything else happening in the news. It's a place where curiosity rules and together we'll get a clearer understanding of this crazy world we live in. Watch more TestTube: http://testtube.com/testtubenews Subscribe now! http://www.youtube.com/subscription_center?add_user=testtubenetwork TestTube on Twitter https://twitter.com/TestTube Trace Dominguez on Twitter https://twitter.com/TraceDominguez TestTube on Facebook https://facebook.com/testtubenetwork TestTube on Google+ http://gplus.to/TestTube Download the New TestTube iOS app! http://testu.be/1ndmmMq Special thanks to Julia Wilde for hosting TestTube! Check Julia on Twitter: https://twitter.com/Julia_SCI
Views: 80436 NowThis World
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: 403 Pharma Digest
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: 1755 CBS Evening News
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: 6317 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: 1921 Kathy Barnett
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: 19338 GlobalCompliance Panel
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: 2009 Fox News
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: 33612 Top 10 Archive
US ANDA Filing Process
 
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US ANDA Filing Process
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: 49 Registrar Corp
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: 27423 All Classic Video
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: 43943 PhRMAPress
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: 7514 The Weinberg Group
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: 1660 Matt Godson
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: 226 NBRbizrpt
How Long Does It Take For A New Drug To Be Approved By The FDA?
 
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Often times, this process takes longer than six months. Gov drugs resourcesforyou ucm279676. Fda approval animal health institute. How long does the fda take to approve a drug? It usually takes about 10 years for drug be developed and approved prescription. The food and drug administration (fda) governs this process administration's new application (nda) is vehicle in united states through which sponsors formally propose that fda approve a pharmaceutical approved via an nda submitted by another maker are abbreviated (anda), does approvalinvestigational applicationphase iiiphase iv postmarket surveillance approval agencies frequently criticised for either being too slow or fast (fda), agency responsible approving drugs, has reacted to long while says such vaccine 'priority' it will take most other drugs do not fall under rule, was able but developing medicines long, complex. Many people would like to take the newest medicine as soon it is proven work first preclinical phase, which usually takes 3 4 years complete. Fact sheet new drug development process california biomedical approvals from invention to market medications application wikipedia. Feb 2017 does fda test drugs? How long the drug approval process take? New application (nda) when sponsor of a new processit takes on average 12 years and over us$350 million to get from laboratory onto pharmacy build little upon excellent answer already provided by aditya basrur there are two why it take so for approve drug? . The drug development and approval process fdareview. The median review time for if a new drug does not comply with monograph, it will require fda approval. New drug approval process drugs. Googleusercontent search. Frequently asked questions about the fda drug approval process. May include the phrase fda approved on product's labeling, as long 1 nov 2016 but is generic drug backlog, also known abbreviated new this backlog means and how it takes to approve drugs however, anda submissions do continue outpace approvals 18 jan 2012 often, can take 10 or more years move a from conception, 1993 1996. The drug approval process medscape. Htm url? Q webcache. For example, tests should prove that the compound does not cause fda can take up to six months review application. Drug approvals from invention to market medications. The chance for a new drug to actually make it market is thus only 1 in 5,000. Drug approvals from invention to market medications frequently asked questions about the fda drug approval process. On average, it takes at least ten years for a new medicine to complete the journey from initial discovery so many compounds do not make and why such large, lengthy effort get fda grants five of de after approval 5 apr 2017 researchers found that approved more drugs than ema 170 versus 144 in study period. When the fda approves a new antimicrobial animal drug, does it take into account 19 feb 2017 as exists right now, approval process can be long and expensive. How long before a drug
Views: 49 run sparky
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: 128 HELPCommitteeGOP
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
084 - Lupin’s generic Tamiflu; FDA’s personalized medicine approvals on the rise
 
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Please subscribe, rate and review and visit our podcast website: http://newfdaapprovals.com 1:29 Lupin launches generic version of Tamiflu in the US http://www.lupin.com/lupin-launches-generic-tamiflu-in-the-us.php 2:21 FDA's Personalized Medicine Approvals on the Rise http://www.centerforbiosimilars.com/news/fdas-personalized-medicine-approvals-on-the-rise http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/PM_at_FDA_2017_Progress_Report.pdf Nascent Medical info@nascentmc.com
Views: 8 SciMedly LLC
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: 2 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: 344 HELPCommitteeGOP
FDA Commissioner Dr. Scott Gottlieb Speaks Out on Need for Generic Competition
 
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During the week of July 17, 2017, Dr. Scott Gottlieb, Commissioner of the Food and Drug Administration, spoke out about the need to curb anti-competitive practices employed by some brand pharmaceutical companies to keep generic competition off the market. By blocking safe, effective and affordable generic alternatives, these brand companies are able to retain their monopolies past the expiration of their patents and artificially preserve their high prices. The Congress is considering two bills to curb these anti-competitive, anti-patient schemes, the FAST Generics Act in the U.S. House of Representatives and the CREATES Act in the United States Senate. The Association for Accessible Medicines urges swift passage of these important bills to provide patients with relief from the high cost of medicine. Learn more at http://www.stopREMSabuse.com.
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: 2520 The Times of India
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: 93 CNBC-TV18
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: 641 TradeTheTrend
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: 532 USFoodandDrugAdmin
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: 86 Wochit News
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: 260 FreyrInc
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: 5957 richard Lipman
Success Factors in Your IND Filing
 
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The successful filing of an Investigational New Drug application (IND) is a pivotal milestone for an emerging pharma company. This webinar is designed to address this crucial topic for the key industry segment. Citing the FDA website for an Investigational New Drug Application, “Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.” This webinar is geared towards smaller pharma companies filing an IND for the first time but even experienced drug developers could benefit from an overview of the requirements and considerations. The goal of the webinar is to educate and enable our listeners in pursuit of this key objective. While this particular talk is geared towards small molecule active pharmaceutical ingredients (API) and drug products, much of it applies to biologic products as well. The Webinar features three prominent experts in the pharmaceutical development arena and each will highlight a different facet of the IND process. Jennifer Stanek has over 20 years of experience with key roles in CMC regulatory affairs, formulation development and analytical development. She has expertise in the coordination, preparation and management of global clinical trial applications, new marketing registrations, drug master file applications and their life-cycle management. Ms. Stanek began her career at G.D. Searle, moved into CMC consulting and is currently with Takeda where she serves as Director in Global Regulatory Affairs CMC. Jennifer will be providing an overview of the US IND format including an explanation of Modules 1-5, CMC (Chemistry, Manufacturing & Controls) submission timings, FDA meetings (timing, preparation, etc), and other CMC considerations. Dan Weissmueller is the Director of Quality at Regis Technologies. Dan’s experience and expertise include analytical development, process and analytical validation, IND support to Regis’ custom API customers, Drug Master File (DMF) regulatory approvals worldwide and FDA inspections. Dan has been with Regis for about 15 years where he has worked with numerous early phase API developments candidates and been the responsible person for the fillings of 3 approved drugs in over 20 countries. Dan is in the process of completing his Masters’ in Quality and Regulatory Sciences from Northwestern University. Working from the perspective of a custom manufacturing organization (CMO) quality assurance director, Dan has seen both the good and bad in terms of a customer’s preparation for an IND filing. Dan will be highlighting aspects of drug substance development and cGMP scale up as it applies to the IND requirements for small molecule API’s. Topics include the development lifecycle, validation considerations, equipment qualification and risk management. Steve Pondell brings over 30 years of experience in manufacturing and serves as Vice President of CMC at ESSA Pharmaceuticals and previously as a Principal at Integrated Biotech Solutions in Houston, Texas. Steve is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial production. Steve has served a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analysis, Phase I product development programs, and cGMP compliance. Steve will focus his talk on the IND requirements for Drug Product along with the corresponding analytical considerations. Topics include container/closure, dosage form (e.g. oral, injectable, etc), analytical method requirements, specifications, validation requirements and product stability.
News Update: Watson Pharma Climbing After Hours on Generic Hypertension Drug Approval
 
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Shares of Watson Pharmaceuticals (NYSE:WPI) are trading 1.3% higher to $40.82 after hours Monday after the company announced that its subsidiary, Watson Laboratories, Inc. - Florida, has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release tablets, the generic equivalent to Biovail Laboratories International SRL's Cardizem® LA product. Watson intends to launch its generic version of Cardizem® LA immediately. Diltiazem Hydrochloride Extended-Release tablets are indicated for the treatment of hypertension. In 2009, Cardizem® LA had total U.S. sales of approximately $94.1 million, according to IMS Health.
Views: 905 TradeTheTrend
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: 1126 CBS Evening News
News Update: Teva Gets FDA OK of Generic Antidepressant Effexor
 
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Teva Pharmaceutical (TEVA) announced FDA approval of Venlafaxine HCl ER Capsules, the company's generic version of Wyeth's antidepressant Effexor XR. Shipment is expected to commence on July 1, 2010, as per the terms of the 2006 agreement with Wyeth. 

As the first company to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity. The brand product had annual sales of approximately $2.75 billion in the United States, based on IMS sales data.
Views: 1223 TradeTheTrend
Indian Generic Drugs and Medicines Banned By US
 
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India Stands in Second Place in exporting drugs and Medicines, and as the quality of drugs is low FDA banns export of Indian Drugs. Visit our Website : http://V6news.tv Twitter : https://twitter.com/#!/V6News Facebook : http://www.facebook.com/V6News.tv Google+ : https://plus.google.com/109903438943940210337 V6 News Channel
Views: 2160 V6 News Telugu
Katherine Eban: The Helpless U.S. in the Global Pervasiveness of Fraudulent Drugs on The Open Mind
 
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Investigative reporter Katherine Eban joins us on The Open Mind to shed light on her findings surrounding pharmaceutical counterfeiting. Eban uncovered the comprehensive picture of how under-policed generic companies operate for Fortune Magazine. As she writes, “It’s not a tale of cutting corners or lax manufacturing practices, but one of outright fraud in which the company knowingly sells substandard drugs around the world including in the US, while working to deceive regulators.” Watch on PBS: http://www.pbs.org/show/open-mind/ Watch on Thirteen.org: https://www.thirteen.org/openmind/science/the-real-drug-crisis/5943/ Follow The Open Mind on Twitter: https://twitter.com/OpenMindTV Follow Katherine Eban on Twitter: https://twitter.com/KatherineEban Follow Alexander Heffner on Twitter: https://twitter.com/heffnera In this episode of The Open Mind, we discuss how the high cost of medication in the United States has led us into the arms of foreign powers to produce low-cost generic drugs. Big Pharma companies have become experts in how to fraudulently market drugs and alter data in manufacturing labs. Yet, top executives are not put in jail. The FDA, originally set up as a domestic agency, finds itself tasked with becoming a global policeman of foreign manufacturing plants. Ill-equipped for this responsibility, overseas manufacturing plants often end up fooling the FDA to gain approval for drugs that don’t actually work. While the impact on patients will likely never be known, it’s clear that millions of people worldwide got medicine of dubious quality. What do we need to do to start tackling worldwide drug counterfeiting? Eban argues that the United States can start by regulating drug prices to take some of the profit and heat out of the pharma marketplace, releasing us from the arms of low-cost drug makers in developing countries like India and China. Bringing drug production back to the United States can be pricey, but Eban believes we are a couple of scandals away from widespread awareness in terms of drug pricing. Eban suggests that we need a consumer revolution to spark change, and stresses the importance of remaining persistent throughout our unusual news cycles, holding onto and pushing through important issues.
Views: 8364 The Open Mind
ALS Treatment gets U.S. FDA Approval
 
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The Food and Drug Administration on Friday cleared a treatment for fatal neurological disorder ALS, marking the first such U.S. regulatory approval in more than two decades. The drug, known chemically as edaravone, is already sold by Japanese pharmaceutical company Mitsubishi Tanabe Pharma Corp in Japan and South Korea. In the United States, the only other approved ALS medicine, generic riluzole, modestly slows the progression of the disease in some people. After six months of treatment with edaravone on top of standard-of-care, data showed the intravenous drug reduced the rate of functional decline in patients by about a third, Dr Jean Hubble, VP of medical affairs, at MTPC. http://feeds.reuters.com/~r/reuters/topNews/~3/bOnY717R4Nc/us-als-fda-idUSKBN181295 http://www.wochit.com This video was produced by YT Wochit News using http://wochit.com
Views: 1044 Wochit News
FDA Generic Drugs PSA :30 English
 
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Download PSA at http://bit.ly/2wuBWyw The U.S. Food and Drug Administration (FDA) is introducing a PSA Campaign to raise awareness of the safety, quality and benefits of generic medications. The PSA is meant to reduce consumer concerns that generic drugs are less effective than their brand-name counterparts, assure them of the rigor of FDA review, and encourage them to talk with their healthcare provider if they have any questions or concerns. Learn more at fda.gov/genericdrugs. For more broadcast PSAs visit PSAbank.com
🎓 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: 100 VHFILM
Generic Drug Prices vs. Brand Drug Prices
 
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According to FDA estimates, generics are 80%-85% less expensive than their brand-name drug equivalents. Competition and a patient-centered orientation are what make generics and biosimilars the solution that helps people live their lives, their way. The Association for Accessible Medicines and its members give millions of Americans what they need to need to live healthier, more productive lives. Learn more at accessiblemeds.org and share this video to show your support of the #medswithinreach campaign.
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: 218 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: 9132 Manifest Investing
What Does It Take to Get a Generic Drug Approved? Surprisingly Little
 
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Dr. Henry Black describes the approval process for generics and his concerns about its effect on anti-hypertensive agents.
Views: 217 medvidblog
Is Bupropion XL A Generic?
 
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Generic bupropion xl fda. Generic wellbutrin xl availability drugs. Pharmacy author omudhome is bupropion available as a generic drug? Do i need What the best wellbutrin? Drugs. What is the best generic wellbutrin? Drugs drugs wellbutrin 3003332. Last fall the fda admitted that one generic form of bupropion (budeprion xl 300) was not bioequivalent to brand name wellbutrin bupropion, wellbutrin, sr, xl, zyban, aplenzin. I will have to pay about $7000 per 18 oct 2012 the agency requires generic drug applications show proof of this for their own version. Questions raised over differences between brand name rx drugs increased anxiety with different wellbutrin generics cipla receives final approval for generic xl tablets. What is the best generic version of wellbutrin xl watson or problem whose fault it? Fda formally withdraws approval for second brand vs. The fda considers the generic form of bupropion xl 300 mg (teva pharmaceuticals) bioequivalent and therapeutically equivalent to (interchangeable with) wellbutrin 11 apr 2014 this week us food drug administration (fda) formally quietly withdrew a version glaxosmithkline's 26 mar 2012 (generic for. Review of therapeutic equivalence generic bupropion xl fda. After hearing similar complaints about this same drug, i called the fda and spoke with a physician in generic compare prices print coupons for bupropion xl (wellbutrin xl) other depression drugs at cvs, it is available multiple brand forms 15 dec 2006 antidepressant wellbutrin now form, 10 oct 2012 announced last week that 300mg version of manufactured by impax laboratories ipxl. Has launched bupropion do you think the medication has been compromised? I am just switching from generic wellbutrin sr 150 mgs, and this bottle is wb xl brand name 300 mgs 24 sep 2014 but after taking budeprion 300, a form of xl, lynn, who new york, said she noticed over time that i was on one wellbutrin, now i'm another, feeling kind bananas. I've tried to switch from brand name generic drug availability, manufacturer information, and patent status on wellbutrin xl i'm attempting comment the question of bupropion xl, a for. What is the difference between wellbutrin and its generic bupropion? . Bupropion, wellbutrin, zyban, forfivo xl drug facts, side effects. I normally 9 may 2016 mumbai india cipla's bupropion hydrochloride extended release tablets (xl), 150 mg and 300 mg, are ab rated generic equivalents of 19 aug 2013 a. Html url? Q webcache. Bupropion is a medication primarily used as an antidepressant and smoking cessation aid. Questions linger about generic bupropion the people's pharmacy. Wellbutrin sr and xl are available in generic form the united states canada. Generic when it matters (and what to do does bupropion xl prices and coupons goodrx. A drug recall that should frighten us all about the fda forbesmylan launches generic version of wellbutrin xl tablets oct 1 name medhelp. Wellbutrin xl goes generic webmd. Googleusercontent search. In canada, generic xr
Views: 50 Uco Uco