A CDRH Webinar explains which medical device manufacturers are required to notify FDA of a permanent discontinuance or interruption in the supply of c...
CBER cautions ValeoMD that it is marketing a human cell, tissue, or cellular or tissue-based product without the necessary BLA or IND.
FDA issues an RFI for a contractor to deploy artificial intelligence-based capabilities to support CDER drug product assessments and business operatio...
CalciMedica says it is transitioning an ongoing randomized open-label study to a blinded placebo-controlled trial for Auxora (in patients with Covid-1...
Sen. Chuck Grassley says President Trump said at a Republican senatorial luncheon that he still wants to see drug pricing legislation passed by Congre...
FDA says that drug developers are interested in applying (quantitative) structure-activity relationship models that have been improved by agency resea...
FDA issues an immediately-in-effect guidance to help address manufacturing limitations or supply chain issues arising from the Covid-19 public health ...
FDA issues a guidance on adverse event reporting priorities during the Covid-19 pandemic.