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Federal Register notice: FDA makes available a draft guidance on Referencing the definition of device in public documents.[ Price : $8.95]
Federal Register notice: FDA classifies the traumatic brain injury eye movement assessment aid into medical device Class 2 (specia...[ Price : $8.95]
Biogen says it will submit a final clinical trial protocol to FDA 3/2022 for a required post-marketing trial of its controversial ...[ Price : $8.95]
FDA denies a petition questioning Eugia Pharmas use of an ANDA for a generic Makena autoinjector.[ Price : $8.95]
Oncology Center of Excellence director Richard Pazdur and chief of medical oncology Julia Beaver call for changes in the developme...[ Price : $8.95]
FDA denies a Par Sterile Products petition saying it failed to raise valid scientific or regulatory issues and was submitted as a ...[ Price : $8.95]
FDA posts a draft guidance entitled Inspection of Injectable Products for Visible Particulates.[ Price : $8.95]
CDRH Office of Product Evaluation and Quality director William H. Maisel tells an industry conference that the agency is planning ...