[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a proposed collection of information on exemptions from substantial equivalence req...[ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves a collection of information entitled Unique Device Identific...[ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on hypertension in...[ Price : $8.95]
FDA denies Eclats petition to have unapproved neostigmine methylsulfate injectable products removed from the market because petiti...[ Price : $8.95]
CDRH patient safety senior advisor Jay Crowley retires from FDA to join regulatory consulting firm USDM Life Sciences as vice pres...[ Price : $8.95]
FDA approves Baxters Feiba indicated for preventing or reducing the frequency of bleeding episodes in patients with hemophilia A o...[ Price : $8.95]
Amgen reports that its Phase 3 DESCARTES study of evolocumab in patients with high cholesterol met its primary endpoint of percent...[ Price : $8.95]
FDA says it would determine on a case-by-case basis whether an ANDA or 505(b)(2) application citing Tevas ProAir as the reference ...