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
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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
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, 17 hours 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, 1 day ago Amid harsh prescription, get-well card from US drug regulator Economic Times, 2 months 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, 5 days 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 week ago 6/21/16 - ANDA Approvals Set To See Significant Increase In 2016 - Research and Markets Pharmacy Choice, 1 week ago
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 Outsourcing, 1 week ago
StockMarketWire.com - 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 Wire, 1 week ago
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 Exchange, 1 week ago Consort Medical PLC DEV610 update ADVFN UK, 1 week ago
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.com, 2 weeks ago Generic Drug Stock Warning Comes True As Endo Crashes Seeking Alpha, 1 month ago Generic drug backlog persists as FDA slowly clears applications BioPharma Dive, 1 month ago
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