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FDA Sets Review Period for Eraxis

06/23/2008

Federal Register Notice: FDA has determined the regulatory review period for Eli Lilly’s Eraxis is 3,476 days for the purpos...

ADM Alliance Nutrition Code Change

06/23/2008

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor's drug labeler code for AD...

FDA Replaces Phrase ‘GMP Regulations’

06/23/2008

Federal Register Final rule: FDA is amending its medical device regulations to implement a nomenclature change and to ensure accur...

Temporary Marketing Permit Info Sent to OMB

06/23/2008

Federal Register Notice: FDA’s proposed collection of information, “Temporary Marketing Permit Applications — 21...

Guidance on Electronic Postmarketing Reports

06/12/2008

Federal Register Notice: FDA is making available a draft guidance for industry, Providing Regulatory Submissions in Electronic For...

Guidance on Antibiotic Susceptibility Test Labeling

06/12/2008

Federal Register Notice: FDA is making available a draft guidance for industry, Updating Labeling for Susceptibility Test Informat...

Comments Sought on Veterinary Feed Directive Drugs

06/05/2008

Federal Register Notice: FDA seeks comments on reporting and recordkeeping requirements for distribution and use of Veterinary Fee...

Pharmaceutical Science Committee to Meet

06/05/2008

Federal Register Notice: FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will meet 7/22-23/08,...

Panel to Discuss Hoffmann-La Roche’s Actemra

06/05/2008

Federal Register Notice: FDA’s Arthritis Advisory Committee will meet 7/29, from 8:30 a.m. to 3:30 p.m. at the Hilton Washin...

FDA Amends Hearing Aid Labeling Regs

06/02/2008

Federal Register Proposed rule and direct final rule: FDA is proposing to amend its regulations on hearing aid labeling to referen...