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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...[ Price : $8.95]
FDA accepts for filing a CV Therapeutics sNDA and NDA for expanded indications for Ranexa.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on voting procedures for advisory committee meetings.[ Price : $8.95]
Federal Register Notice: FDA sends a proposed collection of information on a guidance for cooperative manufacturing arrangements f...[ Price : $8.95]
Endo and Pennwest file suit against Impax protesting its ANDA for oxymorphone HCl extended release tablets.[ Price : $8.95]
Federal Register Notice: FDA sends a proposed collection of information on a recommended glossary and education outreach to suppor...[ Price : $8.95]
Federal Register Notice: FDA sends a proposed collection of information on device third-party review to the Office of Management a...