, 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 month ago
Woodcock: FDA hits ANDA backlog reduction goal ahead of schedule - Pharmacist.com, 1 month ago
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Image source: . Income investors often hunt for stocks in the healthcare sector because demand for healthcare isn't as tightly tied as other sectors to economic whims and whispers. However, not every dividend-paying stock in healthcare deserves a ...Motley Fool, 4 days ago
Although FDA drug, biologic, and medical device user fees have netted the agency $7.67 billion from manufacturers in the last quarter century, the drug or device approval process has not kept pace. In an Avalere analysis , fees have measurably ...Wolters Kluwer Law & Business, 5 days ago Devicemakers See Lower Fees in MDUFA 2017 FDA News, 3 weeks ago
With rise in US FDA warning letters and import alerts to Indian pharma companies in recent years for not complying with good manufacturing practices, cash rich large and mid sized Indian companies are increasingly looking at the option of acquiring ...PharmaBiz, 1 week ago
Q2 2016 Amphastar Pharmaceuticals Inc Earnings Call TEXT version of Transcript ================================================================================ Corporate Participants ...Yahoo! Finance, 1 week ago Mylan NV (MYL) Heather M. Bresch on Q2 2016 Results - Earnings Call Transcript Seeking Alpha, 2 weeks ago Amphastar Pharmaceuticals' (AMPH) Management on Q2 2016 Results - Earnings Call Transcript Seeking Alpha, 2 weeks ago Momenta Pharmaceuticals' (MNTA) CEO Craig Wheeler on Q2 2016 Results - Earnings Call Transcript Seeking Alpha, 2 weeks ago
TELIGENT : Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q)
This "Management's Discussion and Analysis of Financial Condition and Results of Operations" section and other sections of this Quarterly Report on Form 10-Q contain forward-looking statements within the meaning of Section 27A of the Securities Act ...4 Traders, 2 weeks ago
In this interview with , Vivek Partheeban, CEO of Caplin Point Labs talks about his company's growth prospects, entry into the US market and more. Edited excerpts: Sales and profits are up by 21 per cent and 27 per cent respectively. From where ...Economic Times, 2 weeks ago
Aug. 2, 2016 An anticipated uptick in generic drug submissions is leading the FDA to lower its fees for approval applications and supplemental filings next fiscal year. ANDAs filed in fiscal 2017 will drop more than $5,500 to $70,480 per ...FDA News, 3 weeks ago Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2017 Federal Register, 3 weeks ago Generic Drug User FeeAbbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active... Pharmacy Choice, 4 weeks ago
/PRNewswire/ -- Teligent, Inc. (NASDAQ:TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced its financial results for the second quarter ended June 30, 2016. Second Quarter 2016 Highlights Full Year 2016 Revised ...Nasdaq, 3 weeks ago Teligent Announces Second Quarter 2016 Results BioSpace, 3 weeks ago Teligent Inc Announces Second Quarter 2016 Results Pharma Focus Asia, 3 weeks ago
Webcast Titles/Dates: 10 Aug: Pharmaceuticals I 12:00-1:30pm ET 17 Aug: Pharmaceuticals II 12:00-1:30pm ET 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 ...Regulatory Affairs Professionals Society, 3 weeks ago Webcast: RAC (US) Exam Preparation Series (2016) Regulatory Affairs Professionals Society, 2 months ago
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