FDA warns Miami, FL-based US Chem Labs and Bronx, NY-based Helix Chemical that they are selling unapproved and misbranded versions of the popular bran...
FDA publishes an ICH draft guideline on post-approval safety data that is available for comment.
FDA clears a Nanox AI 510(k) for HealthFLD, an artificial intelligence software that provides automated qualitative and quantitative analysis of liver...
Former FDAer Naomi Schwartz says medical device companies must prioritize cybersecurity compliance to meet a stricter FDA enforcement emphasis.
FDA clears a Masimo 510(k) for its MightySat Medical, an over-the-counter fingertip pulse oximeter.
FDA makes available a draft guidance entitled Use of Data Monitoring Committees in Clinical Trials.
Federal Register notice: FDA issues a final rule to amend its regulations to address the use of master files by applications licensed under the Public...
FDA accepts for priority review a Lykos Therapeutics NDA for midomafetamine capsules used in combination with psychological intervention for treating ...
