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Attention! All Involved With Generic Drugs: Due Soon – A New Reporting Requirement

admin November 13, 2012 Drugs, Law & Regulatory No Comments

Tags: amendment, API, drug, drugs, DUNS, facilities, FDA, FDASIA, FDF, FEI, GDUFA, generic, manufacturing, PET, Self-identify, User Fee

Assorted Pills

Generic drug manufacturers and certain others are subject to a new reporting requirement. It is perhaps buried in the Generic Drug User Fee Amendment (GDUFA), which was a part of the Food and Drug Administration Safety and Innovation Act (FDASIA) passed on July 9, 2012. Accordingly, FDA published a Federal Register announcement implementing this new requirement on October 2, 2012. This new requirement takes on a new urgency because the report is due 60 days after that announcement or by December 3, 2012. Failure to self-identify will … READ MORE

Medical Device 513g Requests: FDA vs. FDAImports.com, The Battle Rages On

admin April 20, 2012 Law & Regulatory, Medical Devices No Comments

Tags: 510k, 513g, Battle, Costs, FDA, generic, medical device, non-binding, PMA, Request, type

Medical Device 513g Request: FDA vs FDAImports.com

FDA recently issued new guidance regarding how FDA responds to device classification questions submitted under Section 513(g) of the Federal Food, Drug, and Cosmetic Act. In short, a 513(g) Request for Information must be submitted in writing to FDA, must be for a single device, currently costs approximately $3,500 in (up front) user fees, and may take up to 60 days to process. So what does one get for all that time and money? In responding to … READ MORE

Attention! All Involved With Generic Drugs: Due Soon – A New Reporting Requirement

Medical Device 513g Requests: FDA vs. FDAImports.com, The Battle Rages On

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