Federal Register notice: FDA classifies retinal diagnostic software devices into Class 2 (special controls).
FDA commissioner nominee Robert Califf says ways must be found to speed confirmatory trials for drugs given accelerated approval.
FDA places a clinical hold on Dyne Therapeutics IND for a trial of Dyne-251 to treat Duchenne muscular dystrophy.
FDA sends Aurobindo Pharma a Warning Letter over GMP deficiencies cited 8/2021 at its Hyderabad, India-based Unit 1 active pharmaceutical ingredient m...
Mylan Pharmaceuticals recalls one batch of its non-interchangeable Semglee (insulin glargine injection), 100 units/ml, 3mL prefilled pens due to the p...
FDA grants Sensydia a breakthrough device designation for its Cardiac Performance System that measures critical cardiac function.
FDA extends until 2/4 a temporary postponement of certain inspection activities due to the spread of the omicron variant.
FDA launches a REMS Public Dashboard to improve data access and transparency.