Attorney Keeley McCarty warns medical device manufacturers that the government is pursuing False Claims Act cases against companies that promote off-l...
CDER researchers say they are developing a non-inferiority paradigm to assess exposure-response similarity between pediatric and adult patients.
The Sedgwick Recall Index says medical device recalls soared in the second quarter of 2022, while drug recalls remained level with the first quarter.
Federal Register notice: FDA makes available a draft guidance entitled Hydrogen Peroxide- Based Contact Lens Care Products: Consumer Labeling Recommen...
FDA lifts a partial clinical hold on the Curis TakeAim Lymphoma study of emavusertib.
Federal Register notice: FDA makes available a final guidance entitled Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Device...
Federal Register notice: FDA announces a 10/6 Vaccines and Related Biological Products Advisory Committee meeting to discuss the vaccine strain select...
FDA approves a Bayer sNDA for its Mirena intrauterine system for extended use of up to eight years as a contraceptive.
