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Public Workshop on Clinical Trial Requirements

02/16/2005

Federal Register Notice: FDA Philadelphia District, in cooperation with the Society of Clinical Research Associates (SoCRA), will ...

Errors Corrected in Guidance Document List

02/11/2005

Federal Register Notice: FDA is correcting inadvertent errors in a 1/5 Federal Register notice that provided the agency's annual c...

Guidance on Veterinary Drug Residue in Human Food

02/11/2005

Federal Register Notice: FDA is making available a guidance for industry entitled Studies to Evaluate the Safety of Residues of Ve...

Draft Guidance on Clinical Lactation Studies

02/08/2005

Federal Register Notice: FDA is making available a draft guidance for industry entitled Clinical Lactation Studies — Study D...

Guidance on Drug Immunotoxicity Studies

02/08/2005

Federal Register Notice: FDA is making available a draft guidance entitled S8 Immunotoxicity Studies for Human Pharmaceuticals pre...

Guidance on Animal Drug Sponsor Fees

02/08/2005

Federal Register Notice: FDA is making available a guidance entitled Guidance for Industry: Animal Drug Sponsor Fees Under the Ani...

Public Hearing on IRB Adverse Events

02/08/2005

Federal Register Notice of public hearing: FDA is scheduling a public hearing 3/21 in Rockville, MD to consider the process by whi...

Comments Sought on New Dietary Ingredient Safety Info

02/07/2005

Federal Register Notice: FDA is seeking public comment on the procedure by which a manufacturer or distributor of dietary suppleme...

OMB OKs Info on Registration

02/07/2005

Federal Register Notice: FDA’s collection of information entitled “Registration of Producers of Drugs and Listing of D...

Comments Sought on Electronic Records/Signatures

02/07/2005

Federal Register Notice: FDA is seeking public comment on information collection provisions for the agency’s electronic reco...