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About 68 results for "gdufa"

FDA Completes Review of GDUFA Backlog

, 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 ..., 1 week ago

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Industry calls for generics user fees to be reduced

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 the
 GaBi Online1 month ago

GPhA, IPEC Push FDA to Form Working Groups With Industry

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 News1 month ago

FDA places Chinese, Indian generic drugmakers on Red List

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 ...
 FiercePharma1 week ago FDA bans imports from four Indian and Chinese drugmakers  BioPharma Dive1 week ago

Survey Says China to Lead Biologics Boom

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 Magazine1 week ago China Predicted as Fastest Growing Biologics Market Over Next Decade  CPhI.cn2 weeks ago China poised to have the fastest-growing biologics sector over next decade  Manufacturing Chemist2 weeks ago China forecasted as the fastest growing biologics market...  Bio Spectrum Asia3 weeks ago

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 Times1 week ago

USFDA nods to Indian drugs up 84% in 1 year

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 Times3 weeks ago USFDA nods to desi drugs up 84% in 1 year  Times of India3 weeks ago FDA rejects highest number of monthly generic drug applications ever  Pharmacist.com1 month ago FDA works to speed generic drug approvals  Chain Drug Review2 months ago

Washington Healthcare Update - June 27, 2016

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 ...
 Lexology3 weeks ago

Webcast: RAC (US) Exam Preparation Series (2016)

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 Society1 month ago

ANDA Approvals Set To See Significant Increase In 2016 - Research and Markets

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 ...
 Minyanville1 month ago 6/21/16 - ANDA Approvals Set To See Significant Increase In 2016 - Research and Markets  Pharmacy Choice1 month ago
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