We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
This week, the FDA announced a Medical Devices Advisory Committee meeting, availability of a report on postmarketing performance of drug firms, revised draft guidance on biologic promotional labeling and advertising, three draft guidances on cancer clinical trial eligibility criteria, and a request for comments on promoting effective drug development. Read More
In this edition of Quick Notes, the FDA finally OKs a 40-year-old European mainstay antibiotic for uncomplicated UTIs, an immunotherapy for bladder cancer, a generic form of Narcan nasal spray, and a pediatric version of Lutahera — the first-ever radioligand approved for use in children. Read More
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 and regulations that could impact your business. Read More
This edition of Quick Notes looks at FDA clearances and classifications for devices involving cranial implants, Parkinson’s Disease symptoms, at-home blood sampling and robotic microsurgery. Read More
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 and regulations that could impact your business. Read More
A consent decree of permanent injunction against Philips Respironics restricting the production and sale of new CPAP and BiPAP machines and mechanical ventilators at three U.S. facilities has been entered by the U.S. District Court for the Western District of Pennsylvania. Read More
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 of Olympus’ single use ureteroscope system. Read More
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 and regulations that could impact your business. Read More
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 can look to earlier use of drugs from Johnson & Johnson and Bristol Myers Squibb, and HHS funds support a new antibiotic approved for three serious infections. Read More
Over the past week, the FDA published two final guidances on electronic submissions. Draft guidance was issued on data integrity for in vivo BA/BE studies. The agency is also seeking nominations for members on two advisory committees. Read More