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Amphetamine Sulfate Not Withdrawn for S&E

11/10/2010

Federal Register Notice: FDA has determined that amphetamine sulfate, 5 and 10 mg tablets, was not withdrawn from sale for reasons...

Special Control Guidance Available for Tissue Adhesive

11/10/2010

Federal Register Notice: FDA is making available a guidance entitled, Class 2 Special Controls Guidance Document: Tissue Adhesive ...

Comments Extended on PDUFA Reauthorization Meeting

11/10/2010

Federal Register Notice: FDA is reopening until 10/31/11 the comment period for the notice of public meeting that published in the...

FDA Classifies Tissue Adhesive into Class 2

11/10/2010

Federal Register Final rule: FDA is classifying the tissue adhesive with adjunct wound closure device intended for topical approxi...

FDA Science Board Nominees Sought

10/20/2010

Federal Register Notice: FDA is requesting nominations for voting members from academia and industry to serve on the Science Board...

Guidance on INDs with Live Biotherapeutic Products

10/14/2010

Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Early Clinical Trials with Live Biothera...

FDA OKs Pharmacia & Upjohn sNADA for Dairy Cows

10/14/2010

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Pharmacia & Upjohn supplemental ...

Guidance on Determining if a Study Requires an IND

10/14/2010

Federal Register Notice: FDA is making available a draft guidance, Investigational New Drug Applications (INDs) — Determinin...

Modifications to Device Standards Published

10/04/2010

Federal Register Notice: FDA is making available, “Modifications to the List of Recognized Standards, Recognition List Numbe...

FDA Clarifies P&U sNADAs for Heifer Feed

09/30/2010

Federal Register Final rule: FDA is amending the animal drug regulations to more accurately reflect the recent approval (10/09) of...