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About 58 results for "gdufa"

Generic Drug User Fee Amendments II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers; Request for Information and Comments
Federal Register

How to find the right partner company as GDUFA II proposes a d...

View: 402 The Generic Drug User Fee Amendments (GDUFA) law was introduced in 2012 to speed up access to safe and effective generic drugs. The law mandated the industry to pay user fees to supplement the costs of reviewing generic drug ... PharmaCompass, 1 month ago

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FDA Records Second Highest ANDA Submissions Under GDUFA I

Jan. 19, 2017 Generic drug applications surged in December, with the FDA receiving 235 ANDAs — the second-highest submission record for a particular month since the implementation of GDUFA. Under GDUFA I, submissions reached a peak in June ...
 FDA News3 days ago FDA Seeks Verification of ANDA Holder List for GDUFA II Fees  FDA News1 week ago Anda submissions refuse to-receive standards  SlideShare.net2 weeks ago USFDA issues ANDA Submissions 'Refuse-to-Receive Standards  PharmaBiz3 weeks ago


GDUFA's second iteration emerges from backlogs and negotiations, promising speed, clarity and transparency Source:
 Converter News1 month ago

Final GDUFA Guidance Clarifies Penalties for Unpaid User Fees

Nov. 30, 2016 Generics makers that do not pay user fees on time will be charged penalties and interest, the FDA said in a final Q&A guidance on GDUFA I, the generics user free agreement that expires on Sept. 30, 2017. Sponsors that are ...
 FDA News1 month ago

Q3 results: Five trends to watch out from Indian drugmakers

Analysts predict Q3 to be a tough quarter with revenue growth moderating to 11.7 percent in October-December period compared to 18.4 percent compounded annual growth rate (CAGR) over last 10 years Moneycontrol BureauAs Indian drug makers brace up to ...
 Moneycontrol.com1 week ago

Significant business development progress with year-end revenues in line with expectations

: Vectura Group plc (LSE: VEC) (Vectura, the Group), an industry-leading device and formulation business for inhaled airways disease, today announces an unaudited pre-close update ahead of its results for the nine months ended 31 December 2016, due ...
 PharmiWeb1 week ago Vectura Group plc Pre-close update  ADVFN UK1 week ago Vectura Group plc: Pre-close update  Biotechgate1 week ago Vectura Group plc Interim Results  ADVFN UK1 month ago

Vectura makes 'significant progess' in third quarter

By Josh White Date: Wednesday 11 Jan 2017 LONDON (ShareCast) - (ShareCast News) - Inhaled airways disease device and formulation business Vectura Group announced an unaudited pre-close update on Wednesday, ahead of its results for the nine ... week ago

What Has Driven The Outperformance Of GlaxoSmithKline In 2016 And Why It's Likely To Continue In 2017

In spite of being the best-performing EU Pharma in 2016, GlaxoSmithKline (NYSE: GSK ) is still attractively valued, trading at a discount vs. the sector average EV/EBITDA. I like the company's long-term strategy and diversification approach, with ...
 Seeking Alpha1 week ago
Seeking Alpha

Snippet Roundup: Johnson & Johnson And Shire Make Some Deals, But Disappointments Beckon For Arena And Inotek

Welcome to your weekly roundup of 's snippets short takes on smaller news items. This week, January 2-6, 2017, we had thoughts on the following: J&J (NYSE: JNJ ) joins the Nash pack; Shire (NASDAQ: SHPG ) finds good home for mRNA unit; Arena ...
 Seeking Alpha2 weeks ago

BSE Healthcare index decline by 13% during 2016

The BSE Healthcare index of 69 pharmaceutical companies declined sharply by 12.88 per cent to 14,727.59. points as at the end of December 30, 2016 from previous year closing of 16,905.20 points due to continuous US FDA actions against pharma majors, ...
 PharmaBiz3 weeks ago
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