This edition of Quick Notes reviews the FDA’s approval of Abbott’s transcatheter repair system, Spirair’s nasal septal deviation correction device, de novo approval of Orthobond’s antibacterial coating, and 510(k) clearance…
In its first annual report, the CDER Office of Communications pointed to its three main goals, all of which focus on supporting the public’s faith in the FDA to protect…
Many drug developers could improve the alignment of their quality units and their business units — and potentially avoid Form 483 inspection observations — if they dusted off and applied…
Following ample input and data provided by the FDA, HHS has issued a white paper detailing its progress in reducing what it labels a “decades-long public health issue” — drug…
Most cancer drugs that gain an Accelerated Approval don’t end up showing any clinical benefit in their confirmatory trials, exposing thousands of patients to ineffective therapeutics that may linger on…
Supernus Pharmaceuticals and IntelGenx have recently received Complete Response Letters (CRL) from the FDA requesting additional quality information on their drug-device combination products. Source: Drug Industry Daily
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023, to keep you updated on laws…
In this edition of Quick Notes, Vanda gets a new indication for its antipsychotic drug, Daiichi Sankyo and AstraZeneca get a new indication for their oncology drug, multiple myeloma patients…
A genetic risk assessment for opioid addiction approved by the FDA “may make the opioid crisis worse,” according to 31 physicians, researchers and scientists who ripped the agency and the…
The FDA’s Office of Pharmaceutical Quality (OPQ) finished out 2023 by progressing in all four of its strategic priorities: collaboration, communication, engagement, and innovation, according to its 2023 annual report.…