CDER describes a research study using flow microscopy and convolutional neural networks to monitor changes in product quality attributes.
FDA clears a DiA Imaging Analysis 510(k) for its LVivo IQS, a new artificial intelligence-based vendor-neutral software intended to help users in acqu...
Universal Meditech recalls (Class 1) its Skippack Medical Lab Covid-19 Direct Antigen Rapid Tests (Colloidal Gold) because they did not have FDA autho...
FDA commissioner Robert Califf easily manages criticisms of the agencys handling of the Covid-19 pandemic during a 2/8 House Energy and Commerce joint...
FDA warns the Palm Beach Fertility Center about significant repeat deviations from cellular and tissue regulations.
An FDA Office of Criminal Investigations probe leads to a Puerto Rico federal grand jury indictment against Magnetic Healer and three individuals char...
Federal Register notice: FDA announces the renewal of its Cellular, Tissue, and Gene Therapies Advisory Committee for an additional two years beyond i...
Two former FDAers list eight key takeaways from the new FDA Omnibus Reform Act.
