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About 86 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 month ago

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Motley Fool

3 High-Yielding Healthcare Stocks I'm Not Buying

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 Fool4 days ago

User fee increases still outpace drug, device approvals

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 & Business5 days ago Devicemakers See Lower Fees in MDUFA 2017  FDA News3 weeks ago

Indian cos looking to acquire US FDA approved API & formulation facilities to offset revenue losses

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 ...
 PharmaBiz1 week ago

Edited Transcript of AMPH earnings conference call or presentation 8-Aug-16 9:00pm GMT

Q2 2016 Amphastar Pharmaceuticals Inc Earnings Call TEXT version of Transcript ================================================================================ Corporate Participants ...
 Yahoo! Finance1 week ago Mylan NV (MYL) Heather M. Bresch on Q2 2016 Results - Earnings Call Transcript  Seeking Alpha2 weeks ago Amphastar Pharmaceuticals' (AMPH) Management on Q2 2016 Results - Earnings Call Transcript  Seeking Alpha2 weeks ago Momenta Pharmaceuticals' (MNTA) CEO Craig Wheeler on Q2 2016 Results - Earnings Call Transcript  Seeking Alpha2 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 Traders2 weeks ago

We will continue to grow at 20-25%: Vivek Partheeban, Caplin Point Labs

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 Times2 weeks ago

Expected Rise in Generic Applications to Lower Some User Fees

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 News3 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 Register3 weeks ago Generic Drug User FeeAbbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active...  Pharmacy Choice4 weeks ago

Teligent, Inc. Announces Second Quarter 2016 Results

/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 ...
 Nasdaq3 weeks ago Teligent Announces Second Quarter 2016 Results  BioSpace3 weeks ago Teligent Inc Announces Second Quarter 2016 Results  Pharma Focus Asia3 weeks ago

Webcast: RAC (US) 2016 Exam Preparation Series: Pharmaceuticals I & II

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 Society3 weeks ago Webcast: RAC (US) Exam Preparation Series (2016)  Regulatory Affairs Professionals Society2 months ago
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