Sleepnet recalls its CPAP and BIPAP sleep apnea masks with magnets due to potential interference with certain medical devices.
FDA issues a Form 483 after it finishes a pre-license inspection of Abeonas Cleveland, OH manufacturing facility concerning the companys BLA for pz-ce...
FDA releases a draft guidance entitled Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.
Federal Register notice: FDA corrects a date in a 3/12 notice announcing the availability of a guidance entitled Early Alzheimers Disease: Developing ...
FDA grants Biotronik a beakthrough device designation for the Freesolve below-the-knee resorbable magnesium scaffold, intended for use in individuals ...
FDA launches a new Web page to highlight how it uses inspections to help ensure drug safety and quality.
FDA provides additional information through a just-posted question-and-answer document about its new Quality Manufacturing Maturity Prototype Assessm...
FDA posts a final guidance entitled Controlled Correspondence Related to Generic Drug Development.
