PhRMA suggests changes to an FDA revised draft guidance on the content and format of the Dosing and Administration section of drug labeling.
FDA revises the fact sheets on Janssens Covid-19 vaccine to include a warning about reported adverse events that suggest increased risks of myocarditi...
FDA clears a TytoCare 510(k) for its Tyto Insights for Wheeze Detection, an algorithm for use on the companys existing artificial intelligence-powered...
FDA warns Chatsworth, CA-based Formology Lab about CGMP violations in its production of drugs as a contract manufacturer.
FDA warns Houston, TX- based Dr. Maggie Jeffries/Avanti Anesthesiology about conducting a clinical investigation without a required IND.
FDA amends the emergency use authorization for the Pfizer-BioNTech Covid-19 bivalent vaccine and its use as a single booster dose to include children ...
FDA warns Orlando, FL-based Profounda about CGMP violations in its production of finished drugs as a contract manufacturer.
House Select Subcommittee on the Coronavirus Pandemic Republican leaders ask FDA for communications and interviews relating to potential political int...
