Federal Register notice: FDA sends to OMB an information collection extension entitled Adverse Event Program for Medical Devices.
Federal Register notice: FDA sends to OMB an information collection revision entitled Premarket Notification of Devices.
FDA posts a new CDER manual of policies and procedures (MAPP) 5021.5, Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests...
FDA approves an Ironwood Pharmaceuticals supplemental NDA for Linzess (linaclotide) Linzess (linaclotide) to treat functional constipation in pediatri...
Federal Register notice: FDA seeks comments on an information collection extension on voluntarily submitted medical device regulatory misconduct alleg...
BearCare recalls it rechargeable Walnut Wearable Smart Thermometer due to reports about skin burns and irritation.
FDA accepts for review a Phathom Pharmaceuticals NDA resubmission for vonoprazan, a potassium-competitive acid blocker to treat erosive gastroesophage...
FDA clears a GE HealthCare 510(k) for the Sonic DL a deep learning-based technology designed to dramatically accelerate image acquisition in magnetic...
