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About 47 results for "gdufa"

FDA names and shames firms for failing to pay generics fees

Posted 24/10/2014 No less than 28 generics makers are currently on the US Food and Drug Administration's (FDA) GDUFA (Generic Drug User Fee Amendments) Facility Arrears List for failing to pay generics fees for 2013 and 2014. The GDUFA of 2012 ... GaBi Online, 1 month ago

GPhA Annual Meeting 2015: GDUFA, Quality, and Industry Trends: Part One of Two

On February 9-11, 2015, a record 765 attendees descended on Miami Beach for the Generic Pharmaceutical Association (GPhA's) Annual Meeting . Craig Wheeler, President, Momenta Pharmaceuticals, Inc. delivered the welcoming message, calling GPhA the ...
 JD Supra1 week ago

FDA Warns Mexican Drugmaker for Failing to Pay GDUFA Fees

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to. ...
 FDA News1 month ago

Submission and registration

As the EU Gears up for Major Device Changes, What do Regulatory Pros Need to Know? By RAPS Staff - Published 26 February 2015 In Europe, medical devices currently are regulated much the same way they have been since the 1990s. Now, almost 20 years ...
 Regulatory Affairs Professionals Society1 day ago

Generic Manufacturers Applaud Outgoing FDA Commissioner's Efforts

As news of FDA Commissioner Margaret A. Hamburg's resignation spread, pharmaceutical organizations commended her work as a patient safety advocate, particularly regarding drug approvals. The Generic Pharmaceutical Association (GPhA) and its ...
 Pharmacy Times2 weeks ago GPhA Statement Regarding the Announcement that FDA Commissioner Hamburg Will Step Down  Pharmacy Times3 weeks ago

FDAnews New Management Report: Expediting the FDA Generic Drug Approval Process

PRWeb Expediting the FDA Generic Drug Approval Process **FDAnews Management Report** The FDA continues to struggle to catch up on ANDA approvals. Average time to approve: Three years. Three long ...
 Industrial Info Financials4 weeks ago

Jefferies Weighs In On Specialty Pharmaceuticals After Management Meetings, Raises Price Targets On 5 Stocks

Over the past week, analysts at Jefferies have been holding meetings with senior executives from 29 specialty pharmaceutical (21 branded, eight generic) companies. Following the discussions, here are the main takeaways. Following its busiest year ...
 Benzinga.com1 month ago

Biotech's Riding the Polar Express

PCI Synthesis 2015 Forecast sees the Biotech sector on the extremes By Edward S. Price, President, PCI Synthesis Jan 19, 2015 The biotech sector is one that knows extremes: Were seeing a biotech bubble at the same time were seeing companies ...
 Pharmaceutical Manufacturing Magazine1 month ago

New boss same as the old. FDA's Office of Generic Drugs makes Kathleen Uhl permanent chief

By Kurt R. Karst The news came downon Thursdaythat FDA's Center for Drug Evaluation and Research Director Janet Woodcock, M.D., named Kathleen Cook Uhl, M.D. , as the permanent director of the Office of Generic Drugs (OGD). Although Dr. Uhl has ...
 MedCity News1 month ago

Yen depreciation to impact Japan business revenue: Lupin

A third of Lupin's 72 products are market leaders. The company remains positive on its business outlook. C NBC-TV18 honoured the best in business at the glittering 10th edition of the India Business Leader Awards on Friday. Lupin won the ...
 Moneycontrol.com1 month ago Lupin expects 8-10 product launches in US in second half: Kamal Sharma  India Infoline1 month ago
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