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FDA issues a complete response letter for a Phase 3 trial of BioMarins gene therapy for severe hemophilia A.[ Price : $8.95]
FDA issues an immediately effective guidance to answer questions about some regulatory and policy issues during the Covid-19 publi...[ Price : $8.95]
FDA clears an IlluminOss Medical 510(k) for its Photodynamic Bone Stabilization System for treating fibula fractures.[ Price : $8.95]
FDA clears a Hyperfine Research 510(k) to expand the use of its portable Swoop MRI imaging device to expand its brain imaging indi...[ Price : $8.95]
FDA warns Oxford Medical Instruments that it is marketing unapproved and misbranded new drugs and claiming they can treat Covid-19...[ Price : $8.95]
Federal Register notice: FDA revises its regulations to reflect changes to the agencys organizational structure, including the reo...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for CVM dispute resolution procedures.