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Collection of Info on Smokeless Tobacco Sent to OMB

10/29/2014

Federal Register Notice: FDA’s proposed collection of information, “Information Request Regarding pH of Smokeless Toba...

Comments Sought on FDA-IND Sponsor Communication

10/29/2014

Federal Register Notice: FDA is establishing a docket to receive suggestions, recommendations, and comments from interested partie...

FDA Publishes List of Device Standards

10/17/2014

Federal Register Notice: FDA is publishing “Modifications to the List of Recognized Standards, Recognition List Number: 037,...

Comments Sought on Consumer Tobacco Panel

10/16/2014

Federal Register Notice: FDA is seeking public comment on establishing a probability-based panel of tobacco users. FDA’s Cen...

FDA Sends Collection of Info on Device Tracking to OMB

10/16/2014

Federal Register Notice: FDA’s proposed collection of information, “Medical Devices; Device Tracking — 21 CFR pa...

Guidance on New Chemical Entity Exclusivity on Fixed-Combo Drugs

10/16/2014

Federal Register Notice: FDA is making available a guidance New Chemical Entity Exclusivity Determinations for Certain Fixed-Combi...

Guidance on Veterinary Controlled List of Terms

10/09/2014

Federal Register Notice: FDA is making available a document: Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Pr...

Panel to Discuss NDAs for Myeloma, Iron Loss

10/09/2014

Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 11/6, from 8 a.m. to 5 p.m. at FDA White Oak Cam...

Advisory Board to Toxicological Research to Meet

10/09/2014

Federal Register Notice: FDA’s Science Advisory Board to the National Center for Toxicological Research will meet 11/6, from...

Nominations Sought for Tobacco Committee

10/09/2014

Federal Register Notice: FDA is requesting nominations for voting members to serve on the Tobacco Products Scientific Advisory Com...