FDA publishes a draft guidance on recommended documentation for premarket submissions of medical device software functions.
FDA says it is evaluating a DC federal court ruling remanding to the agency its memorandum of understanding with states on the interstate distribution...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novartis Adakveo (crizanlizumab-tmca).
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sanofis Dengvaxia (dengue tetravalent vaccine, ...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Galdermas Aklief (trifarotene), indicated for t...
FDA approves Insightecs Exablate Neuro for a third indication.
FDA grants breakthrough device designation for TecTraums Pro2cool system to improve concussion outcomes.
A BMJ investigation says a Ventavia Research Group whistleblower informed FDA about multiple irregularities in the companys work testing the Pfizer Co...