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Comments Reopened on Cattle Material Prohibition

03/30/2007

Federal Register Proposed rule: FDA is reopening until 5/14, the comment period for a proposed rule published in the 1/12 Federal ...

Small Changes Made to Rx-Exemption Regs

03/30/2007

Federal Register Final rule: FDA makes editorial changes to citations in the regulations on the prescription-exemption procedure a...

Guidance on Target Product Profiles

03/30/2007

Federal Register Notice: FDA is making available a draft guidance for industry and review staff, Target Product Profile — A ...

Review Period Set for Retevase

03/29/2007

Federal Register Notice: FDA has determined the regulatory review period for Retevase (reteplase) is 1,919 days for extending a pa...

Women’s Health Workshop Slated

03/29/2007

Federal Register Notice: FDA's Office of Women's Health will hold a “Workshop to Develop a Women's Health Information Sharin...

Vaprisol Review Period Set

03/29/2007

Federal Register Notice: FDA has determined the regulatory review period for Astellas Pharma’s Vaprisol is 2,796 days for ex...

Public Meeting on Feed Contaminants

03/29/2007

Federal Register Notice: FDA will hold the public meeting entitled: “Meeting to Present Work-in-Progress on a Method for Ran...

Granular Laxative Products Not GRASE

03/29/2007

Federal Register Final rule: FDA is issuing a final rule establishing that OTC laxative drug products in granular dosage form cont...

Chicago Public Workshop on Trials

03/28/2007

Federal Register Notice: FDA Chicago District and the Society of Clinical Research Associates (SoCRA), will hold a workshop on FDA...

Review Period Set for Infuse Bone Graft Device

03/28/2007

Federal Register Notice: FDA has determined the regulatory review period for SDGI Holdings’ Infuse Bone Graft/LT-Cage Lumbar...