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Federal Register Notice: FDA is making available a draft guidance for industry, Providing Regulatory Submissions in Electronic For...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Federal Register Notice: FDA is making available a draft guidance for industry, Updating Labeling for Susceptibility Test Informat...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

Guidance on SPL Indexing

06/02/2008

Federal Register Notice: FDA is making available a guidance for industry, Indexing Structured Product Labeling. CBER and CDER will...

FDA OKs Lloyd Equine Pain Reliever

06/02/2008

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Lloyd, Inc. ANADA for veterinary...

Mammography System into Class 2

05/30/2008

Federal Register Proposed rule: FDA is proposing to reclassify the full field digital mammography (FFDM) system from Class 3 (prem...

Comments Sought on PTCA Catheter Reclassification

05/30/2008

Federal Register Notice: FDA is seeking comments on the recommendation of the Circulatory System Devices Panel to reclassify Percu...