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During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Over the past week, the FDA endorsed International Council for Harmonisation (ICH) recommendations, in final guidances covering analytical procedure development and validation of such procedures. Read More
This week, a company pares down those giant robotic surgery systems, a drug-coated angioplasty balloon opens coronary arteries with pressure and medication, an ablation system eases the pain of metastatic bone lesions, and a new fixation device stabilizes the sacroiliac joint without the need for lateral screws. Read More
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This edition of Quick Notes looks at the FDA alerts and letters regarding artificial ankle failures, operating tables moving unexpectedly and unlatched incubator panels. Read More
This week, critics complain that the Biden administration just doesn’t get Bayh-Dole, the DOJ hands BioMarin a subpoena, another Humira biosimilar snags FDA OK, and Novo Nordisk sticks a deal for molecular glue. Read More
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This edition of Quick Notes looks at news in the medical device industry with Medtronic exiting the ventilator market, an FDA warning letter for a nasal spray, and FDA clearances for the first robotic assistant for shoulder surgery and an electrophysiological home monitor system. Read More
Over the past week, the FDA issued a final rule adding the Digital Health Advisory Committee to the list of standing committees, final guidance on COVID-19 symptoms in clinical trial subjects, and draft guidance on medical device user fees for small businesses. Read More
This edition of Quick Notes looks at significant drug approvals, including the first cellular therapy for patients with unresectable or metastatic melanoma, a drug to reduce accidental food allergy reactions, Tagrisso with chemotherapy for patients with EGFR-mutated advance lung cancer and a dosage reduction for patients with relapsed or refractory multiple myeloma. Read More
This edition of Quick Notes looks at consequential new drug approvals, including a first drug for frostbite, a first of its kind gene therapy authorization for sickle cell disease and transfusion-dependent beta thalassemia, supplemental approvals for pancreatic and non-small cell lung cancer and a treatment for an inflammatory esophageal condition. Read More