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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...

Info on Orphan Drug Application Forms Sent to OMB

10/07/2014

Federal Register Notice: FDA’s proposed collection of information, “Orphan Drugs; Common European Medicines Agency/Foo...

OMB OKs Info Collection on Drug/Biologic User Fees

10/07/2014

Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on User Fee Waivers, Reductio...

Guidance on Breast Cancer Neoadjuvant Treatment Trials

10/07/2014

Federal Register Notice: FDA is making available guidance for industry entitled Pathological Complete Response in Neoadjuvant Trea...

Tobacco Center Seeks Tours Program Participants

10/07/2014

Federal Register Notice: FDA’s Center for Tobacco Products’ (CTP) Office of Science is inviting participants for its L...