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About 96 results for "gdufa"

FDA, Industry Form Agreement on GDUFA II
Contract Pharma

GDUFA Reauthorization Talks Complete

Sept. 9, 2016 The FDA and industry have finished negotiating the terms for renewing GDUFA, the agency said. A 15-minute meeting involving five FDA officials and three industry representatives ended the negotiations and finalized the terms of ... FDA News, 2 weeks ago
FDA, Industry Form Agreement on GDUFA II Contract Pharma, 3 weeks ago
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Federal Register

FDA finalizes guidance on generic drug facility self-identification

FDA has finalized guidance regarding the self-identification of generic drug producers and the information those facilities must provide. Self-identification is required by FDA to enable the monitoring of generic drugs and to determine user fees for ...
 Pharmacist.com9 hours ago Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry; Availability  Federal Register5 days ago

Generic Drug User Fees; Public Meeting; Request for Comments

Start Preamble Food and Drug Administration, HHS. Notice of public meeting; request for comments. The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the ...
 Federal Register4 days ago

TOM COTTON : Cotton Introduces the Safely Advancing Valuable and Inexpensive New Generic Solutions Act

Contact: Caroline Rabbitt (202) 224-2353 Washington, D.C.- Senator Tom Cotton (R-Arkansas) today introduced the Safely Advancing Valuable and Inexpensive New Generic Solutions Act, or the SAVINGS Act, legislation that would require the Food and Drug ...
 4 Traders5 days ago Cotton Introduces the Safely Advancing Valuable and Inexpensive New Generic Solutions Act  Pharmacy Choice5 days ago

Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Hearing

Introduction Good morning Chairman Moran, Ranking Member Merkley, and members of the Subcommittee. I am Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA or the Agency).
 Pharmacy Choice6 days ago

Sharon Bio Medicine rallies on receiving EIR from USFDA for Taloja plant

SENSEX 28614.10 90.90 0.32% NIFTY 8801.45 25.55 0.29% Industry: Medical/Healthcare Company Sharon Bio-Medicine Ltd Sharon Bio-Medicine is currently trading at Rs. 12.19, up by 2.03 points or 19.98% from its previous closing ...
 Finalaya.com1 week ago

Pharmaceutical Policy Under Clinton

Prediction markets and polls have Ms. Clinton well ahead of Trump in the election, and health issue nonsense notwithstanding, it's likely that come January 20th, we'll be inaugurating another Clinton into the White House. Whatever your political ...
 Seeking Alpha1 week ago

GPhA 2016 Fall Technical Conference

24−26 October 2016 Bethesda North Marriott Hotel and Conference Center North Bethesda, MD, USA Save the date! Join more than 700 generic industry professionals and attend this unique educational conference. Hear presentations from key ...
 GaBi Online1 week ago
Investor's Business Daily

Is EpiPen's Price The FDA's Fault? What's Holding Up New Generics?

EpiPen's rivals keep hitting snags, but overall the drug-competition/drug-price picture is improving. The sudden outbreak of political debate over Mylan's EpiPen in late August led to a grand circle of finger-pointing. Some members of Congress ...
 Marketplace3 weeks ago Is EpiPen's Price The Government's Fault?  Investor's Business Daily3 weeks ago
Freshnews.com

SOCMA's BPTF Pleased with Outcome of Round Two of Generic Drug User Fee Negotiations

WASHINGTON , Aug. 31, 2016 /PRNewswire-USNewswire/ -- The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), today hailed the successful ending of negotiations for the ...
 Minyanville4 weeks ago SOCMA\\'s BPTF Pleased with Outcome of Round Two of Generic Drug User Fee Negotiations  Asian Hospital & Healthcare Management3 weeks ago SOCMAs BPTF Pleased with Outcome of Round Two of Generic Drug User Fee Negotiations  Asian Hospital & Healthcare Management3 weeks ago
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