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About 58 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, 3 weeks 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 News3 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 week 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 week ago Biotech and Generic Drugs: 2015 Trends and Predictions  PharmaceuticalProcessing1 month ago PCI Synthesis Announces 2015 Trends And Predictions  BioSpace1 month ago PCI Announces 2015 Trends and Predictions  SearchBug1 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 News2 weeks 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.com2 weeks ago Lupin expects 8-10 product launches in US in second half: Kamal Sharma  India Infoline2 weeks ago

FDA's Office of Pharmaceutical Quality Revs Up Process to Accelerate ANDA Reviews

In a preview of how the FDA's Office of Pharmaceutical Quality will speed approval of generic drugs, the office is rolling out a framework for ANDA filers to respond to minor agency queries involving chemistry, manufacturing and control issues early ...
 FDA News3 weeks ago

ANDA Backlog, OPQ, Abuse-Deterrent Opioids Among Top CDER Priorities

Addressing the ANDA backlog, setting up the pharmaceutical quality office, and issuing final guidance on abuse-deterrent opioids are among the roughly dozen top priorities for CDER in 2015. CDER Director Janet Woodcock outlined the office's 2015 ...
 FDA News3 weeks ago
FDA News

OGD to Focus on Approvals in Addressing ANDA Backlog

The Office of Generic Drugs is pledging to catch up on a backlog of thousands of ANDAs by October 2017. OGD head Kathleen Uhl outlined this goal in a memo to staff last month that stresses the office's role is to approve as many applications as ...
 FDA News3 weeks ago Office of Generic Drugs to Focus on Approvals in Addressing ANDA Backlog  FDA News1 month ago
Financial Express

Drug firms face ANDA blues

Summary The delay in approval of generic drug applications, which has been slowly declining annually, witnessed its lowest run-rate in the first half of… The delay in approval of generic drug applications, which has been slowly declining ...
 Financial Express1 month ago Approval delays to hurt Indian pharma cos' US sales  Rediff.com2 months ago Drugmakers see US sales hit by delay in new approvals  The Financial Chronicle2 months ago Indian drugmakers see U.S. sales hit by delay in new approvals  The Financial Chronicle2 months ago
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