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Info on Submitting Info to CVM with e-Submission Gateway

08/30/2013

Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry 108 on How To Submit Informa...

FDA Posts Final eCTD Specification Documents

08/26/2013

Federal Register Notice: FDA is making available on its Web site revised final versions of the following four documents that suppo...

Info on ANADAs Sent to OMB

08/26/2013

Comments Sought on New Dietary Ingredients

08/26/2013

Federal Register Notice: FDA is seeking comments on the procedure by which a manufacturer or distributor of dietary supplements or...

Guidance on BE Studies for Risperidone

08/26/2013

Federal Register Notice: FDA is making available a revised draft guidance for industry entitled Draft Guidance on Risperidone. It ...

FDA Transfers Live Cell Wound Care Products to CBER

08/14/2013

Info on Tobacco Health Document Sent to OMB

08/14/2013

Federal Register Notice: FDA’s proposed collection of information, “Tobacco Health Document Submission,” has bee...

Guidance on Radio Frequency Wireless in Devices

08/14/2013

Workshop on Gastroenterology Therapeutics

08/14/2013

Federal Register Notice: CDER will co-sponsor a public workshop 10/21-22 entitled “Gastroenterology Regulatory Endpoints and...

OMB OKs Info on DTC Advertising

08/13/2013