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About 12 results for "gdufa"

FDA to hold public meeting on GDUFA

Posted 08/05/2015 The US Food and Drug Administration (FDA) is seeking specific suggestions on potential changes to the Generic Drug User Fee Act (GDUFA) performance goals and ways to improve procedures, ahead of negotiations to reauthorize the ... GaBi Online, 3 weeks ago

Can generic drug appearance impact patient adherence?

The FDA wants to know how patient perceptions of medications change when pharmacies switch from brand to generic drugs or from one generic to another, as in the case of a change in suppliers. Changes in a drug's size, shape or color can confuse ...
 PharmaceuticalProcessing2 days 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 month 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.com1 month ago Generic Drug User Fees; Public Meeting; Request for Comments  Pharmacy Choice1 month ago Pharma companies eye US complex generics market  Financial Express1 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 month ago

FDA Steps Up Foreign Inspections

New legislation and changes in policy at FDA are leading to better control of the API supply chain. Günay Mutlu/E+/ In September 2011, the US Government Accounting Office (GAO) published a report on the challenges that FDA faced in ...
 Pharmaceutical Executive1 month ago
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