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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...

Nominations Sought for TSE Committee

09/18/2012

Federal Register Notice: FDA is requesting that any industry organizations interested in participating in the selection of a nonvo...

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...

Meeting on Study Data Exchange Standards

08/14/2012

Federal Register Announcement of meeting: “Regulatory New Drug Review: Solutions for Study Data Exchange Standards” to...

Animal Drug Sponsor Changed to Elanco

08/06/2012

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for two NADAs, for Stresni...