The American Hospital Association asks the Biden Administration to require FDA to take immediate actions to increase the supply of intravenous (IV) so...
Former FDA principal deputy commissioner Janet Woodcock joins the board of directors at Every Cure, a nonprofit organization that looks at repurposing...
Philips Respironics recalls (Class 1 device correction) its Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators regardin...
Medtronic recalls (Class 1) its MiniMed Insulin pumps due to concerns about reduced battery life in certain situations.
An Elucid 510(k) gains clearance for its PlaqueIQ imaging analysis software to help physicians diagnose cardiovascular disease.
A Reuters article looks into drug GMP issues raised by FDA inspections over the past decade at Thermo Fisher's Greenville, NC drug contract manufactur...
FDA updates CDRHs Customer Collaboration Portal to track the progress of PMA applications and accept Small Business Determination requests.
FDA says that 22% of new molecular entities required postmarketing requirements or postmarketing commitments to address knowledge gaps on drugdrug int...
