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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Committee to the list of standing committees, final guidance on COVID-19 symptoms in clinical trial subjects, and draft guidance on medical device user fees for small businesses.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
Senate Majority Whip Dick Durbin (D-Ill.) and Senator Mike Braun (R-Ind.) have urged the FDA to take “swift” action to update its enforcement tools to address the alarming proliferation of dangerous and misleading social media content promoting prescription drugs. Read More
Over the past week, the FDA issued a final rule on BLAs and master files. Final Guidance was issued on charging for investigational drugs under an IND. Draft guidance was issued on use of data monitoring committees. Product specific guidances were published. The agency also announced continuation of its site visit training program for its regulatory project managers, extended the comment period for the draft guidance on master protocols for drug and biological product development and amended a request for nominations for voting members for the Genetic Metabolic Diseases advisory committee. Read More
This week, your watch can start alerting you to sleep apnea, a fingertip clip can monitor your daytime blood oxygen, and a robotic exoskeleton can help restore mobility to spinal cord injury patients. But in a refreshing win for actual humans, a large study finds that the surgeon’s hands are just as good as robotic techniques in arthroscopic knee repair. 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
Over the past week, the FDA issued final guidance on reporting drugs and biologicals under Section510(j)(3) of the FD&C Act. Draft guidance was issued on notifications of a discontinuance or interruption in manufacturing under Section 506C of the FD&C Act. The agency also announced meetings of the Oncologic Drugs Advisory Committee and the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. Read More