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Panel to Discuss Janssen NDA for TB

09/26/2012

Federal Register Notice: FDA’s Anti-Infective Drugs Advisory Committee will meet 11/28, from 8 a.m. to 5 p.m. at DoubleTree ...

Public Meeting on Patient-Focused Drug Development

09/24/2012

Federal Register Notice: FDA will hold a public meeting 10/25 from 9 a.m. to 12:30 p.m. on the agency’s patient-focused drug...

FDA Seeks Participant Notification for Drug Development Meetings

09/24/2012

Federal Register Notice: FDA is requesting that patient stakeholders notify the agency by 10/3 of their intention to participate i...

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

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...

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...