Due to supply shortage concerns, FDA allows two-month expiry date extensions on some epinephrine auto-injectors, 0.15 mg and 0.30 mg, distributed by I...
Federal Register notice: FDA opens a public docket to receive suggestions and comments on the agencys publication of its surrogate endpoint table.
Federal Register notice: FDAs chief scientist denies a request for a hearing on a CDER proposal to refuse approval of a Pharmaceutical Manufacturing R...
FDA releases its latest batch of Warning Letters that include Boule Medical, Cardiomed Supplies, Gaeltec Devices and Leventon.
Federal Register notice: FDA classifies the active implantable bone conduction hearing system into Class 2 (special controls).
Federal Register notice: FDA classifies high-flow humidified oxygen delivery devices into Class 2 (special controls).
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Novo Nordisks Rebinyn (coagulation fact...
FDA clears an Align Technology 510(k) for the Invisalign treatment with mandibular advancement, a clear aligner solution for Class 2 teeth alignment c...