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Federal Register notice: FDA reopens the comment period on a 3/1 notice entitled Discussion Paper: Artificial Intelligence in Drug...[ Price : $8.95]
FDA says Phoenix-AZ-based Peace Wellness Center is marketing stem cell products and exosomes that require approval through a BLA o...[ Price : $8.95]
A ProPublica/Pittsburgh Post-Gazette in-depth report says Philips Respironics kept from FDA adverse event reports describing serio...[ Price : $8.95]
A just-released Form FDA-483 shows that four months after a 10/2022 Warning Letter, the agency cited the firm again after an inspe...[ Price : $8.95]
Attorney Maarika Kimbrell discusses the challenges facing CBER as it reorganizes to meet PDUFA 7 commitments and an increase in IN...[ Price : $8.95]
FDA grants Ideaya Biosciences a Fast Track designation for IDE161 for treating certain adult patients having advanced or metastati...[ Price : $8.95]
Ionis Pharmaceuticals says it will file an NDA early next year after reporting Phase 3 topline results of olezarsen in people with...[ Price : $8.95]
FDA clears a Trax Surgical 510(k) to market its Trax Compression Screw System that offers a wide range of bone screws for osteotom...