Federal Register notice: FDA makes available a draft guidance entitled Population Pharmacokinetics (PK) to assists sponsors in applying PK during drug...
Altaire Pharmaceuticals recalls numerous brands of over-the-counter eye drops sold at CVS Health due to sterility concerns.
Federal Register notice: FDA releases a draft guidance on Hormonal Contraceptive Drug Product Development.
Hamilton Medical recalls its Hamilton-G5 Ventilators due to the potential for error messages to be displayed and resulting in the ventilator to stop w...
FDA issues a Warning Letter to Abington Memorial Hospitals institutional review board after a bioresearch monitoring inspection found violations.
GE Healthcare recalls its Giraffe and Panda i-Res Infant Warmers because the bedside panels and latch areas of the warmers can crack or break if the u...
FDA clears an Icotec 510(k) for the Vader One pedicle screw system for spine surgical procedures.
Janssen Pharmaceutical Companies files a BLA for Darzalex (daratumumab) that seeks approval of a new subcutaneous formulation for treating certain pat...