Former CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger says FDA is likely to expand its use of new FDA Medic...
FDA posts a draft guidance entitled Ethical Considerations for Clinical Investigations of Medical Products Involving Children.
FDA grants QT Imaging a 510(k) clearance for its QTscan to calculate the fibroglandular volume of the breast and the ratio of that to total breast vol...
Philips Respironics recalls (Class 1) certain BiPAP (bi-level positive airway pressure) ventilators that may contain a plastic contaminated with a non...
FDA releases an immediately-in-effect guidance entitled Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA...
Federal Register notice: FDA sends to OMB an information collection extension for abbreviated new animal drug applications.
Federal Register notice: FDA renews its Arthritis Advisory Committee for an additional two years.
Federal Register notice: FDA makes available a final guidance entitled Electronic Submission Template for Medical Device 510(k) Submissions.
