FDA issues an FDA-483 with 13 observations from an inspection at Indias Alkem Laboratories.
FDA publishes an overview guidance on using performance criteria under the expanded abbreviated 510(k) program.
FDA extends by three months its review of an AbbVie NDA for elagolix in endometriosis-associated pain to review additional information related to the ...
Innovative Health Solutions asks FDA to require pre-clinical and clinical trials for any proposed devices demonstrating substantial equivalence to its...
FDA announces the availability of four International Council on Harmonization drug guidances.
FDA clears a Lensar 510(k) for the Lensar Laser System with Streamline IV, that expands the platforms capabilities to include the creation of the corn...
Federal Register notice: FDA seeks comments on an information collection extension for Petition To Request an Exemption From 100% Identity Testing of ...
FDA allows the de novo marketing of called IDx LLC.s IDx-DR, a software program that uses an artificial intelligence algorithm to analyze images of th...