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FDA issues a guidance on agency thinking on quality agreements in contract manufacturing arrangements.[ Price : $8.95]
FDA says its activities in soliciting comment on bioequivalence testing methodologies are sufficient and no additional activities ...[ Price : $8.95]
President-elect Donald Trump meets with Indiana state health commissioner Jerome Adams, presumably as a candidate for HHS secretar...[ Price : $8.95]
Intarcia Therapeutics files an NDA for ITCA 650 (exenatide) for treating Type 2 diabetes.[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Medtronics Core Valve System for patent extension purpose...[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Pharming Groups Ruconest for patent extension purposes 3...[ Price : $8.95]
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Federal Register Notice: FDA makes available a draft guidance entitled E11(R1) Addendum: Clinical Investigation of Medicinal Produ...