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FDA releases a draft guidance on electronic submission of Risk Evaluation and Mitigation Strategies.[ Price : $8.95]
FDA warns medical professionals to not use alcohol pads or benzalkonium chloride antiseptic towelettes made by China-based Foshan ...[ Price : $8.95]
FDA, National Cancer Institute and the Society of Urologic Oncology announce an 11/28 public workshop to improve the conduct of ad...[ Price : $8.95]
FDA clears a GE Healthcare 510(k) for the Senographe Pristina with Self-Compression, the first 2D digital mammography system that ...[ Price : $8.95]
CDER posts a new Manual of Policies and Procedures on Filing Review of Abbreviated New Drug Applications.[ Price : $8.95]
Federal Register notice: FDA announces the end of support for Version 1.2 of Clinical Data Interchange Standards Consortium Study ...[ Price : $8.95]
FDA publishes a finalized guidance on Medical Devices Advisory Committee panel meetings.[ Price : $8.95]
CDRH officials say the Centers early feasibility study program is benefitting sponsors, FDA, and the public.