FDA Review posts product approval summaries for the week ending 7/12/2019.
Federal Register notice: FDA makes available a draft guidance entitled Population Pharmacokinetics (PK) to assists sponsors in applying PK during drug...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Federal Register notice: FDA releases a draft guidance on Hormonal Contraceptive Drug Product Development.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...