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FDA Corrects Notice on Tobacco Establishment Registration

09/18/2012

Federal Register Notice: FDA is correcting FDA form numbers in a 5/3 Federal Register notice seeking comment on the proposed exten...

FDA Corrects Notice on Tobacco Ingredients

09/18/2012

Toxicological Research Meeting Planned

09/18/2012

Federal Register Notice: FDA will hold a meeting of the Science Advisory Board to the National Center for Toxicological Research 1...

FDA Releases Bioequivalence Recommendations

09/14/2012

Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommend...

Comments Sought on Electronic Submission Gateway

09/14/2012

Federal Register Notice: FDA seeks comments on the use of the FDA Electronic Submission Gateway (ESG) and the Safety Reporting Por...

FDA Records Sponsor Change for 3 ANADAs

09/14/2012

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for three ANADAs from Teva...

Comments Sought on CLIA Waivers

09/14/2012

Federal Register Notice: FDA is seeking public comment on collections of information associated with Clinical Laboratory Improveme...

Public Meeting on Generic Drug User Fee Act

12/08/2011

Federal Register Notice: FDA will hold a public meeting 12/19 to discuss proposed recommendations for enacting a Generic Drug User...

Info on MedWatch Sent to OMB

12/07/2011

Federal Register Notice FDA is announcing that a proposed collection of information, “MedWatch: The FDA Medical Products Rep...

Meeting to Discuss Biosimilar Biologic User Fees

12/07/2011

Federal Register Notice: FDA will hold a public meeting 12/16 to discuss the proposed recommendations for a user fee program for b...