Democratic leaders of the House Energy and Commerce Committee urge FDA to promptly issue the overdue draft guidance on drug and medical device clinica...
FDA posts a Medtronic update on its NIM electromyogram endotracheal tubes, including actions to take in the event of airway obstruction.
An FDA safety alert warns about the risks related to using smartwatches or smart rings that claim to measure blood glucose levels without piercing the...
FDA approves a Johnson & Johnson supplemental BLA for Tecvayli (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks in patie...
United Therapeutics sues FDA over its decision to permit Liquidia to seek a second indication for its Yutrepia by amending its pending NDA rather than...
Federal Register notice: FDA amends its standing advisory committee regulations to add the new Digital Health Advisory Committee.
FDA cautions device manufacturers to evaluate the performance data provided by third-party labs for use in agency submissions.
CBER publishes a SOPP for the administrative handling, review, and reporting of postmarketing requirements and commitment submissions.