FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

List of Approved PMAs Posted

06/07/2007

Federal Register Notice: FDA is publishing a list of premarket approval applications that have been approved to inform the public ...

Chantix Review Period Set

06/07/2007

Federal Register Notice: FDA has determined the regulatory review period for Chantix is 2,401 days for extending a patent which cl...

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...

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Federal Register Notice: FDA is making available a draft guidance for industry, Malaria: Developing Drug and Nonvaccine Biological...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Federal Register Notice: FDA is making available draft guidance for industry: Providing Regulatory Submissions in Electronic Forma...