Despite FDA skepticism, the agency’s Circulatory System Devices Panel advisory committee endorsed Abbott’s TriClip, a transcatheter edge-to-edge repair system intended to treat tricuspid regurgitation. Source: Drug Industry Daily
FTC and HHS are jointly seeking more intel on how the practices of two types of pharmaceutical drug middlemen — group purchasing organizations (GPOs) and drug wholesalers — may be…
Two online marketers of semaglutide (Wegovy/Ozempic) and tirzepatide (Mounjaro) received FDA warning letters for selling the unapproved, untested drugs to consumers through their websites. Source: Drug Industry Daily
A federal judge in Texas has handed the Biden administration a win in its quest to control Medicare drug pricing, dismissing a lawsuit that challenged the legality of negotiating Medicare…
The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) pathway would be restrictive to manufacturers in the cell and gene therapy spaces, the Alliance for Regenerative Medicine and the…
Following on the heels of a House subcommittee meeting to discuss FDA inspections of foreign drug manufacturers, the FDA released a scathing 483 inspection report of an active pharmaceutical ingredient…
Wayne Pines, Senior Director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, reviews the FDA’s recent actions related to marketing…
A peer-reviewed analysis of data from a previous study of Masimo’s pulse oximetry device shows accurate measurement of oxygen saturation (SpO2) regardless of skin tones or pulse strength. Source: Drug…
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…
Approved BLAs may continue to incorporate by reference information on drug substances, drug substance intermediates, and drug products (DS/DSI/DP) contained in master files if the data were initially referenced when…