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Somatuline Depot Review Period Set

11/17/2008

Federal Register Notice: FDA has determined the regulatory review period for Somatuline Depot is 3,629 days for extending a patent...

Guidance on Tropical Disease Priority Review

10/20/2008

Federal Register Notice: FDA is making available a draft guidance, Tropical Disease Priority Review Vouchers. It explains to stake...

OMB OKs Marketing Permit Info Collection

10/17/2008

Federal Register Notice: FDA’s collection of information, “Temporary Marketing Permit Applications,” has been ap...

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Federal Register Notice: FDA is making available a draft guidance document for FDA advisory committee members and FDA staff, Votin...

Info on Cooperative Biologic Mfg. Sent to OMB

11/19/2007

Federal Register Notice: FDA’s proposed collection of information, “Draft Guidance for Industry: Cooperative Manufactu...

Info on Animal Drug User Fees Sent to OMB

11/19/2007

Federal Register Notice: FDA’s proposed collection of information, “Animal Drug User Fees and Fee Waivers and Reductio...

Info on CGMP for Medicated Feeds Sent to OMB

11/19/2007

Federal Register Notice: FDA is announcing that a proposed collection of information, “Current Good Manufacturing Practice R...

Info on Glossary for IVD Labels Sent to OMB

11/19/2007

Federal Register Notice: FDA’s proposed collection of information, “Medical Devices: Recommended Glossary and Educatio...

Info on Device Third-Party Review Sent to OMB

11/19/2007

Federal Register Notice: FDA’s proposed collection of information, “Medical Devices Third-Party Review Under the Food ...