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U.S. senators Mike Enzi (R-WY) and Maggie Hassan (D-NH) introduce legislation that would help protect patients from counterfeit me...[ Price : $8.95]
Federal Register notice: FDA publishes an order to exempt a list of Class 2 devices from 510(k) requirements, subject to certain l...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Regulatory Considerations for Human Cells, Tissues, and Cel...[ Price : $8.95]
A Lassman Law & Policy petition asks FDA to require substantial evidence of effectiveness before approving a BLA for Mesoblasts Ry...[ Price : $8.95]
CDER accepts a C-Path qualification plan for glutamate dehydrogenase as a safety biomarker for drug-induced liver injury.[ Price : $8.95]
Four House Energy and Commerce Committee Democrats ask FDA for information on its response to fraudulent Covid-19 antibody test sc...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance on quality considerations for cannabis and cannabis-derived compound...[ Price : $8.95]
Federal Register notice: FDA announces its support for use in regulatory submissions of the current version of an international st...