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Guidance on In Vitro Companion Diagnostics

07/14/2011

Federal Register Notice: FDA is making available a draft guidance, In Vitro Companion Diagnostic Devices. It is intended to assist...

Panel to Discuss Transvaginal Surgical Mesh Safety

07/14/2011

Comments Sought on CVM Science-based Decisions

07/13/2011

Federal Register Notice: FDA is seeking comments on the information collection requirements for appeals of science-based decisions...

Grants Funds Available for Pharmaceutical Education Initiative

07/13/2011

Federal Register Notice: FDA is announcing the availability of grant funds to support a cooperative agreement with the National In...

FDA Signs MOU with Medscape, WebMD

07/13/2011

Federal Register Notice: FDA is providing notice of a memorandum of understanding (MOU) between FDA and Medscape and WebMD LLC to ...

Animal Drug Sponsor Name Changed

11/10/2010

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor's name from North American...

Amphetamine Sulfate Not Withdrawn for S&E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Federal Register Notice: FDA has determined that amphetamine sulfate, 5 and 10 mg tablets, was not withdrawn from sale for reasons...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...