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Comments Sought on Rodent Carcinogenicity Testing

03/18/2013

Federal Register Notice: FDA is seeking comments on a proposed change to the International Conference on Harmonization Sl guidance...

Panel to Vote on Allergan Dermal Filler

03/18/2013

Panels to Discuss Endo NDA for Testosterone Deficiency

03/14/2013

Federal Register Notice: FDA’s Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advi...

FDA, Xavier Plan Device Conference

03/13/2013

Federal Register Notice: FDA Cincinnati District will co-sponsor with Xavier University a public conference entitled “FDA/Xa...

Cooperative Agreement to Support Regulatory Research

03/13/2013

Federal Register Notice: FDA intends to accept and consider a single source application for award of a cooperative agreement to th...

Info on Influenza A Virus Reagents Sent to OMB

03/13/2013

Federal Register Notice: FDA’s proposed collection of information, “Guidance on Reagents for Detection of Specific Nov...

Guidance on Dispute Resolution Above the Division Level

03/13/2013

Federal Register Notice: FDA is making available a draft guidance entitled Formal Dispute Resolution: Appeals Above the Division L...

Guidance on Tablet Scoring Labeling

03/13/2013

Federal Register Notice: FDA is making available a guidance for industry entitled Tablet Scoring: Nomenclature, Labeling, and Data...

FDA Plans Meetings on Antimicrobial Use in Livestock

03/07/2013

Federal Register Notice: FDA plans to hold five meetings to provide an opportunity for public dialog and feedback on challenges fa...

FDA Withdraws 19 NADAs, 1 ANADA

03/07/2013

Federal Register Final rule/notice: FDA is withdrawing approval of 19 NADAs and one ANADA and is amending the animal drug regulati...