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Move Against Office of Internal Affairs Not Enough, He Says

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A former victim of CDRH enforcement abuse says the recent revocation of FDA Office of Internal Affairs authority in favor of the H...

FDA Accepts Ranexa sNDA and NDA

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FDA accepts for filing a CV Therapeutics sNDA and NDA for expanded indications for Ranexa.

Guidance on Advisory Panel Voting Procedures

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Federal Register Notice: FDA releases a draft guidance on voting procedures for advisory committee meetings.

Info on Cooperative Biologic Mfg. Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on a guidance for cooperative manufacturing arrangements f...

Patent Suit Filed on Opana ANDA

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Endo and Pennwest file suit against Impax protesting its ANDA for oxymorphone HCl extended release tablets.

Info on Glossary for IVD Labels Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on a recommended glossary and education outreach to suppor...

Info on Device Third-Party Review Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on device third-party review to the Office of Management a...

Info on CGMP for Medicated Feeds Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on CGMP regulations for medicated feeds to the Office of...

MOU with Feed Control Officials

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Federal Register Notice: FDA provides a memorandum of understanding between FDA and the Association of American Feed Control Offic...