CDER launches a Controlled Substances Program to coordinate Center activities and emerging issues around various controlled substances.
CDRH releases three new learning modules on aspects of the 510(k) third-party review program.
FDA announces a 3/9 workshop on Detecting Circulating Tumor DNA for Cancer Screening.
FDA says the Medtronic recall of its MiniMed 600 Series insulin pumps, due to a missing or broken retainer ring, is Class 1.
FDA issues a guidance on 510(k) submissions for peripheral vascular atherectomy devices.
The Office of Clinical Pharmacology says its annual report and the report from its Division of Applied Regulatory Science are available online.
Attorney Curtis Dombeck says a recent Federal Circuit Appeals Court decision has revolutionized determination of the country of origin for drugs to be...
Federal Register notice: FDA seeks comments on an information collection extension for FDA Rapid Response Surveys.