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Review Period Set for Tracleer

05/07/2003

Federal Register Notice: FDA has determined the regulatory review period for Tracleer is 2,176 days for the extension of a patent ...

FDA Establishes S&E Conditions for Ingrown Toenail Products

05/07/2003

Federal Register Final rule: FDA is issuing a final rule establishing conditions under which over-the-counter ingrown toenail reli...

Guidance on Exposure-Response Relationships

05/06/2003

Federal Register Notice: FDA is making available a guidance for industry entitled Exposure-Response Relationships--Study Design, D...

Panel to Discuss Lilly Hormone Deficiency sNDA

05/06/2003

Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 6/10, from 8:30 a.m. to 5 p.m...

FDA Panel to Discuss Safety/Efficacy of Ipecac Syrup

05/06/2003

Federal Register Notice: FDA’s Nonprescription Drugs Advisory Committee will meet 6/12, from 8 a.m. to 5 p.m. at the Holiday...

FDA Sends Info on Animal Drug Reports to OMB

05/05/2003

Federal Register Notice: FDA has submitted to the Office of Management and Budget information on Records and Reports Concerning Ex...

Notice on Bioterrorism Meeting Corrected

05/05/2003

Federal Register Notice: FDA is correcting errors in a document that appeared in the 4/8 Federal Register announcing a public meet...

Criteria on Third Party Accreditation Detailed

04/28/2003

Federal Register Notice: FDA is releasing the criteria it will use to accredit persons for the purpose of conducting inspections o...

OMB OKs Info on Small Business Qualification

04/28/2003

Federal Register Notice: FDA’s collection of information entitled “Fiscal Year 2003 MDUFMA Small Business Qualificatio...

Info on Third Party Accreditation Sent to OMB

04/28/2003

Federal Register Notice: FDA’s proposed collection of information on the criteria FDA intends to use to accredit third parti...