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Authorized Generic Drug Info Required

09/29/2008

Federal Register Direct final rule/proposed rule: FDA is amending its regulations to require that the holder of an NDA submit cert...

Guidance on End-of-Phase 2A Meetings

09/26/2008

Federal Register Notice: FDA is making available a draft guidance for industry, End-of-Phase 2A Meetings. It provides information ...

Approved PMA List Posted

09/26/2008

Federal Register Notice: FDA is publishing a list of approved PMAs whose safety and effectiveness summaries are available through ...

MedWatch Info Sent to OMB

09/24/2008

Federal Register Notice: FDA’s proposed collection of information, “MedWatch: Food and Drug Administration Medical Pro...

Panel to Discuss Genzyme BLA

09/24/2008

Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 10/21, from 8 a.m. to 5 p.m. ...

Finished Drug GMP Info Sent to OMB

09/24/2008

Federal Register Notice: FDA’s proposed collection of information, “Current Good Manufacturing Practice Regulations fo...

FDA Corrects Harmonization Notice

09/22/2008

Federal Register Notice: FDA is correcting a document number in a 7/11 Federal Register notice that announced the availability of ...

Info on Accredited Persons Inspections Sent to OMB

08/29/2008

Federal Register Notice: FDA’s proposed collection of information, “Requests for Inspection Under the Inspection by Ac...

FDA OKs Cross Vetpharm sNADA for Bovine Respiratory Disease

12/07/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Cross Vetpharm Group Ltd. supple...

Guidance on Advisory Panel Voting Procedures

11/19/2007

Federal Register Notice: FDA is making available a draft guidance document for FDA advisory committee members and FDA staff, Votin...