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About 84 results for "gdufa"

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 Online, 1 month ago
FDA works to speed generic drug approvals Chain Drug Review, 1 month ago
8 Significant Generic Drug Approvals in 2015 Pharmacy Times, 1 month ago

1 images for "gdufa"

Drug Store News, 2 months 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

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 ...
 Lexology17 hours 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 Times1 day ago Amid harsh prescription, get-well card from US drug regulator  Economic Times2 months 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 Society5 days 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 week ago 6/21/16 - ANDA Approvals Set To See Significant Increase In 2016 - Research and Markets  Pharmacy Choice1 week ago

What's Driving the CMO Market? The Opportunities and Challenges Ahead

Judging by a resurgence of IPO activities since the new year and increasing product commercialization news in the pharma and biopharma industries, the future of these industries is clearly on the rise. And as the market for generics continues to ...
 American Pharmaceutical Outsourcing1 week ago

Consort Medical hikes divi as revenues rise - Consort Medical's revenue increased by by £92.1m to £276.9m in the year to the end of April with Bespak delivering continued growth of 10.8% to £117.2m. In its first full year in Consort, Aesica revenue grew 102.1% to ...
 Stock Market Wire1 week ago

DEV610 update

Consort Medical plc 16 June 2016 DEV610 is a dry powder inhaler initially for use in Mylan's generic version of Advair which they have submitted for US approval FDA has set potential approval date (GDUFA date) at 28 March 2017 DEV610 expected to ...
 London Stock Exchange1 week ago Consort Medical PLC DEV610 update  ADVFN UK1 week ago

FDA rejects highest number of monthly generic drug applications ever

FDA, criticized for pumping out too many generic drug applications in a bid to stimulate market competition, has applied the brakes in recent months. The regulator rejected a record 190 abbreviated new drug applications (ANDAs) for the month ended ...
 Pharmacist.com2 weeks ago Generic Drug Stock Warning Comes True As Endo Crashes  Seeking Alpha1 month ago Generic drug backlog persists as FDA slowly clears applications  BioPharma Dive1 month ago
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