The U.S. FDA’s draft guidance for selection of a predicate device in 510(k) submissions is part of a larger effort to overhaul the 510(k) program, but industry’s response is that this draft guidance goes too far.
The U.S. FDA is assembling a new advisory committee specifically focused on treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee, or GeMDAC, will be tasked with providing agency reviewers independent expert recommendations regarding regulatory applications as well as advice on scientific and policy issues.
Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.
Integra Lifesciences Holdings Corp. agreed to acquire Acclarent Inc. from Johnson & Johnson’s Ethicon Inc. subsidiary for $275 million in cash at closing with a further $5 million contingent on achievement of certain regulatory milestones.
Edwards Lifesciences Corp. set analysts a-spin ahead of its investor day activities with the revelation it plans to launch its critical care unit as a stand-alone public company next year. Edwards expects that dividing the business will allow it to focus on cardiovascular and surgical markets.
Both Vertex Pharmaceuticals Inc.’s Casgevy (exagamglogene autotemcel, exa-cel) and Bluebird Bio Inc.’s Lyfgenia (lovotibeglogene autotemcel, lovo-cel) received U.S. FDA approval Dec. 8, providing 16,000 American sickle cell patients who have recurring vaso-occlusive events with access to the first cell-based gene therapies.
After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have refused to trod. In releasing a draft framework to help federal agencies decide whether to exercise a federal march-in on patent rights protecting taxpayer-supported drugs and other inventions, including medical devices.
The U.S. FDA’s draft rule for lab-developed tests (LDTs) has proven to be every bit as controversial as expected, although the controversy is only marginally about the workload that would come with rulemaking.
After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have refused to trod. In releasing a draft framework to help federal agencies decide whether to exercise a federal march-in on patent rights protecting taxpayer-supported drugs and other inventions, including medical devices, the Department of Commerce’s National Institute of Standards and Technology included price as a factor in considering whether a product is “reasonably” available, as required under the 1980 Bayh-Dole Act.
The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities.
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