FDA issues Regenerative Processing Plant a Warning Letter based on a 2023 inspection of the firms Palm Harbor, FL, manufacturing plant that found sign...
An April inspection of Japans Taenaka Kogyo ends in a four-observation Form FDA-483 that cites significant GMP violations.
FDA posts a Form FDA-483 issued to Biocon Biologics at the end of a July inspection at the firms Bengaluru, India manufacturing facility.
FDA grants Travere Therapeutics full approval for Filspari (sparsentan) for slowing kidney function decline in adults with primary immunoglobulin A ne...
Federal Register notice: FDA seeks comments on an information collection revision entitled Pharmaceutical Distribution Supply Chain; Drug Supply Chain...
Federal Register notice: FDA makes available a draft guidance entitled Incorporating Voluntary Patient Preference Information over the Total Product L...
FDA publishes a draft guidance on incorporating voluntary patient preference information in medical device total life cycle regulatory decisions.
Federal Register notice: FDA sends to OMB an information collection reinstatement entitled Yale-Mayo Clinic Centers of Excellence in Regulatory Scienc...
