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About 16 results for "gdufa"

GPhA Annual Meeting 2015: GDUFA, Quality, and Industry Trends:...

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 Supra, 2 months ago

IPEC - Americas Publishes Position Paper on FDA Inactive Ingredient Database

Release date- 22042015 - Issues related to inaccurate and incomplete information on excipients referenced in the U.S. FDA Inactive Ingredient Database (IID) and FDA policies and guidance related to the review of inactive ingredients in ANDAs ...
 Pharmacy Choice1 day ago
Financial Express

FDA kicks off generic drug user fee reauthorization process

FDA announced Tuesday that it will begin accepting comments regarding the first-ever reauthorization of the Generic Drug User Fee Act (GDUFA), a user fee arrangement which funds much of FDA's generic pharmaceutical regulatory activities. GDUFA was ...
 Pharmacist.com2 days ago Generic Drug User Fees; Public Meeting; Request for Comments  Pharmacy Choice3 days ago Pharma companies eye US complex generics market  Financial Express1 week ago Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments  Pharmacy Choice1 month ago

PBOA Hosts Workshop

On March 30, the Pharma & Biopharma Outsourcing Association (PBOA) held its first Regulatory/Legislative Workshop. The one-day event, held in the Washington, DC offices of Arnall Golden Gregory , was free for members of the PBOA, and featured ...
 PharmaceuticalProcessing1 week ago

FDA Steps Up Foreign Inspections

New legislation and changes in policy at FDA are leading to better control of the API supply chain. G√ľnay Mutlu/E+/ In September 2011, the US Government Accounting Office (GAO) published a report on the challenges that FDA faced in ...
 Pharmaceutical Executive2 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 Alpha1 month ago IGI Laboratories' (IG) CEO Jason Grenfell Gardner on Q4 2014 Results - Earnings Call Transcript  Seeking Alpha1 month 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 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
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