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About 80 results for "gdufa"

Contract Pharma

Industry Groups Applaud GDUFA Agreement

Industry organizations applauded the agreements reached by FDA and representatives of the generic drug manufacturing industry on reauthorization of the Generic Drug User Fee Amendments (GDUFA) for a new five-year period, covering FY2018 to FY2022. ..., 18 hours ago

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Federal Register

FDA Releases Guidance on GDUFA Self-Identification

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement. The Generic Drug User Fee Amendments of 2012 (GDUFA) requires generic-drug facilities to annually submit identification ...
 BioPharm International6 hours ago Abbreviated New Drug Application SubmissionsPrior Approval Supplements Under Generic Drug User Fee Amendments; Guidance for Industry; Availability  Pharmacy Choice5 days ago FDA finalizes guidance on generic drug facility self-identification  Pharmacist.com3 weeks ago Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry; Availability  Federal Register4 weeks ago

GDUFA II Goal: Evaluate 90 Percent of Priority Submissions in Eight Months

Oct. 24, 2016 The FDA intends to review 90 percent of priority review ANDAs deemed complete within eight months, according to the agency's GDUFA II commitment letter. The full commitment letter further explains the performance goals the FDA ...
 FDA News13 hours ago

David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, Remarks on GDUFA II

You currently are not registered for any FirstWord Pharma services. Register to FirstWord Pharma for free access to 10 articles every 30 days: You can also: Wait 11 days for your content allowance to be renewed. Sign up for a free trial to ...
 FirstWord Pharma18 hours ago
Financial Express

India urges US to talk on social security pact

We have strongly urged the US to engage in negotiations for signing of a Totalisation Agreement. It is being heard and I hope there will be a positive response from their side, Nirmala Sitharaman told. (PTI) India today strongly urged the US to ...
 Financial Express2 days ago India urges US to discuss pact to avoid double taxation  Times of India2 days ago India "strongly" urges US to talk on social security pact  CFO India1 day ago

Single-brand retail trade: US asks India to relax local sourcing norms

India pushes for greater agri trade, quick conclusion of totalisation pact Business heads meet Nirmala Sitharaman IPR policy reiterates India's stance: Sitharaman India pushed for a greater market access for agricultural export and better ...
 Business Standard India1 day ago

Prescribed Reading: AZ sell-off, Merck wins ESMO, generics dominate

Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry ...
 BioPharma Dive1 week ago

Know the Rules! FDA's New Regulations Change Responsibilities For ANDA Filers

, nearly thirteen years after passage of the Medicare Modernization Act (MMA), FDA published a final rule in the Federal Register implementing amendments and revisions to title 21 of the Code of Federal Regulations (C.F.R.) to conform the ...
 JD Supra1 week ago

CMO/CDMOs: Looking Ahead

Last year, I started off by setting up a broad perspective on the size of the global CMO/CDMO sector, carefully curating figures from PharmSource, ICON, and others to illustrate the growth rate of the business. That was a lot of work, and the scene ...
 American Pharmaceutical Outsourcing2 weeks ago

Cambrex: Overblown Concerns Present Attractive Entry Opportunity Into Growing Market

Why Does this Opportunity Exist? Cambrex Corporation (NYSE: CBM ) fell when Gilead (NASDAQ: GILD ) reported disappointing earnings related to price/volume mix of its Hepatitis C drug, Harvoni. Cambrex produces several drugs for Gilead, primarily ...
 Seeking Alpha2 weeks ago Short Cambrex: The Biggest Loser In Gilead's Hepatitis C Sales Downturn  Seeking Alpha1 month ago
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