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About 50 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, 2 months 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 month 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 News2 months ago

Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments

Notification of public hearing; request for comments. CFR Part: "21 CFR Part 15" Citation: "80 FR 11966" Document Number: "Docket No. FDA-2014-N-1168" Page Number: "11966" "Proposed Rules" SUMMARY: The Food and Drug Administration ...
 Pharmacy Choice3 weeks ago

Mylan (MYL) Heather M. Bresch on Q4 2014 Results - Earnings Call Transcript

Operator Good day, ladies and gentlemen, and welcome to Mylan Incorporated Fourth Quarter and Year-End 2014 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer ...
 Seeking Alpha3 weeks ago IGI Laboratories' (IG) CEO Jason Grenfell Gardner on Q4 2014 Results - Earnings Call Transcript  Seeking Alpha3 weeks ago

Statement by Ralph G. Neas, President and CEO, GPhA, Regarding the Reintroduction of the FDA SOS Act

PRESS RELEASE WASHINGTON, DC (February 26, 2015) - GPhA applauds Reps. Leonard Lance (R-N.J.) and Rep. Anna G. Eshoo (D-Calif.) for the bipartisan reintroduction of the Food and Drug Administration Safety Over Sequestration (FDA SOS) Act, ...
 Pharmacy Times4 weeks ago Generic Manufacturers Applaud Outgoing FDA Commissioner's Efforts  Pharmacy Times1 month ago GPhA Statement Regarding the Announcement that FDA Commissioner Hamburg Will Step Down  Pharmacy Times1 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 month 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 Financials1 month ago FDA's Office of Pharmaceutical Quality Revs Up Process to Accelerate ANDA Reviews  FDA News2 months 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.com2 months 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 Magazine2 months ago
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