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Advisory Committee for Pharmaceutical Science to Meet

04/11/2005

Federal Register Notice: FDA’s Advisory Committee for Pharmaceutical Science will meet 5/3 and 5/4, from 8:30 a.m. to 5 p.m....

Info on Temporary Marketing Permits Sent to OMB

04/08/2005

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

FDA Submits Info on State Preemption Exemptions to OMB

04/08/2005

Federal Register Notice: FDA’s proposed collection of information, “State Petitions for Exemption From Preemption R...

FDA Sends Info on Export Recordkeeping to OMB

04/08/2005

Federal Register Notice: FDA’s proposed collection of information, “Exports: Notification and Recordkeeping Requiremen...

Comments Sought on Health/Nutrient Claims

04/08/2005

Federal Register Notice: FDA is seeking public comment on the proposed collection of information associated with submitting notifi...

Public Meeting to Prep for ICH Meeting

04/07/2005

Federal Register Notice: FDA will hold a public meeting 4/20 to provide information and receive comments on the International Conf...

Animal Drug Sponsor Changes to Virbac

04/06/2005

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for NADA 10-886 for Purina...

Latest FDA Warning Letters

04/05/2005

Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following e...

Guidance on Endpoints for Cancer NDAs, BLAs

04/04/2005

Federal Register Notice: FDA is making available a draft guidance for industry entitled Clinical Trial Endpoints for the Approval ...

FDA Corrects Animal Drug Regulations

04/04/2005

Federal Register Final rule: FDA is amending the animal drug regulations to reflect the limitations to conditions of use for produ...