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Science Board to Discuss Melamine Assessment

06/07/2007

Federal Register Notice: FDA is making an amendment to the 5/21 notice of meeting of the Science Board to the FDA to add the follo...

Cefotan Not Withdrawn for S&E

06/07/2007

Federal Register Notice: FDA has determined that Cefotan (cefotetan disodium for injection), equivalent 1 g base/ vial and 2 g bas...

Guidance on Quality Control Material

06/07/2007

Federal Register Notice: FDA is making available a guidance for industry and FDA staff entitled Assayed and Unassayed Quality Cont...

Guidance on Developing Malaria Treatments

06/07/2007

Federal Register Notice: FDA is making available a draft guidance for industry, Malaria: Developing Drug and Nonvaccine Biological...

FDA Sends Dietary Supplement Info to OMB

06/07/2007

Federal Register Notice: FDA’s proposed collection of information, “Substantiation for Dietary Supplement Claims Made ...

Review Period Set for Raplon

06/06/2007

Federal Register Notice: FDA has determined the regulatory review period for Akzo Nobel N.V.’s Raplon is 1,724 days for the ...

FDA OKs Pharmacia & Upjohn NADA

06/06/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Pharmacia & Upjohn NADA for revi...

Joint Panel Meeting on Thiazolidinedione Risks

06/06/2007

Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management...

Guidance on Receipt Date for E-Submissions

06/05/2007

Federal Register Notice: FDA is making available draft guidance for industry: Providing Regulatory Submissions in Electronic Forma...

Advisory Committee Hotline Revised

06/05/2007

Federal Register Notice: FDA has revised the Advisory Committee Information Hotline (1-800-741-8138 or 301-443-0572) by assigning ...