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FDA Proposes No ‘Pedigree’ for Unauthorized Rx Drug Distributors

07/14/2011

Federal Register Proposed rule: FDA is proposing to remove a section of the Prescription Drug Marketing Act (PDMA) regulations req...

Info on Biologic ADEs Sent to OMB

07/14/2011

Federal Register Notice: FDA’s proposed collection of information, “Adverse Experience Reporting For Licensed Biologic...

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Federal Register Notice: FDA is making available a draft guidance, In Vitro Companion Diagnostic Devices.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

FDA OKs Cross Vetpharm ANADA for Calves

07/01/2011

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Cross Vetpharm original ANADA th...

Panel to Discuss Bioequivalence Issues, NTI Drug Products

07/01/2011

Comments Sought on DTC Ad Study

07/01/2011

Federal Register Notice: FDA is seeking comments on the Experimental Study of Comparative Direct-to-Consumer (DTC) Advertising, de...