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Federal Register Notice: FDA releases a draft guidance: Liposome Drug Products: CMC; Human Pharmacokinetics and Bioavailability; a...[ Price : $8.95]
A Government Accountability Office analysis of FDA-ordered postmarket surveillance studies between 3/2008 and 2/2015 finds that 94...[ Price : $8.95]
Federal Register Notice: FDA reopens the comment period on a draft guidance: Human Cells, Tissues, and Cellular and Tissue-Based P...[ Price : $8.95]
CDRH posts a draft guidance on Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medic...[ Price : $8.95]
FDA accepts for filing a Lipocine NDA for LPCN 1021, an oral product candidate for testosterone replacement therapy in adult males...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Prod...[ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on correspondence ...[ Price : $8.95]
FDA issues a revised guidance on information needed with an application for liposome drug products reviewed by CDER.