, Janet Woodcock, director of the FDA Center for Drug Evaluation and Research (CDER) announced that as of July 1, 2016 FDA has met its Generic Drug User Fee Amendments (GDUFA) commitment. According to Woodcock, the agency has completed its goal of ... PharmTech.com, 1 week ago
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Generics makers and industry groups have commented on the Generic Drug User Fee Amendments (GDUFA) reauthorization, calling for lower user fees and greater transparency in theGaBi Online, 1 month ago
As the FDA makes plans for its GDUFA-mandated fiscal 2017 Regulatory Science Plan, industry trade groups are pushing the agency to spend more time communicating its intentions. Speaking at an FDA public meeting on last week, representatives of ...FDA News, 1 month ago
The FDA has placed four Chinese and Indian generic drug facilities on the so-called Red List that bans them from shipping products to the U.S. for failing to pay required fees and not meeting identification requirements. The action by the ...FiercePharma, 1 week ago FDA bans imports from four Indian and Chinese drugmakers BioPharma Dive, 1 week ago
CPhI Worldwide, organized by UBM EMEA, announces the findings of the latest CPhI Pharma Insights report on the Chinese pharma economy. Of the international companies surveyed, 85 percent believe that China is set to have the fastest growing ...Pharmaceutical Manufacturing Magazine, 1 week ago China Predicted as Fastest Growing Biologics Market Over Next Decade CPhI.cn, 2 weeks ago China poised to have the fastest-growing biologics sector over next decade Manufacturing Chemist, 2 weeks ago China forecasted as the fastest growing biologics market... Bio Spectrum Asia, 3 weeks ago
More from: European Pharmaceutical Review, European Pharmaceutical Manufacturer...and 8 other sources
Sun Pharma will be unstoppable if it integrates Ranbaxy well: Amit Rajan, Director, Celogen Life Science
In this interview with , Amit Rajan, Director, Celogen Life Science talks about Indian pharma companies and US FDA process. Edited excerpts: ET Now: What is your understanding of the news flow which has come for Indian pharma sector? Amit Rajan: ...Economic Times, 1 week ago
MUMBAI: Drug approvals given by the US Food and Drug Administration (USFDA) to Indian companies nearly doubled year-on-year, with littleknown firms including MSN Lab, Shasun Pharma, Granules India, Ajanta Pharma and Gland Pharma making a foray into ...Economic Times, 3 weeks ago USFDA nods to desi drugs up 84% in 1 year Times of India, 3 weeks ago FDA rejects highest number of monthly generic drug applications ever Pharmacist.com, 1 month ago FDA works to speed generic drug approvals Chain Drug Review, 2 months ago
Courts Supreme Court Asks Solicitor General to Weigh in on Sandoz v. Amgen On June 20, the Supreme Court asked the solicitor general to weigh in on Sandoz v. Amgen before it decides whether to take up the case. The case could affect how soon ...Lexology, 3 weeks ago
Passing the RAC exam takes hard work and a lot of preparation. As part of a complete study plan for the RAC (US) exam, this popular webcast series can help, particularly with the exam's analysis and application to the workplace components. This RAPS ...Regulatory Affairs Professionals Society, 1 month ago
Research and Markets has announced the addition of the "World Generic Markets Issue 277 (V15 I10)" report to their offering. Research and Markets has announced the addition of the "World Generic Markets Issue 277 (V15 I10)" report to their ...Minyanville, 1 month ago 6/21/16 - ANDA Approvals Set To See Significant Increase In 2016 - Research and Markets Pharmacy Choice, 1 month ago
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