FDA publishes a new final guidance on assessing Covid-19-related symptoms in adults and adolescents who are subjects in clinical trials of drugs to tr...
Five stakeholders make suggestions for changes to an FDA draft guidance on using real-world evidence in medical device regulatory decision-making.
CDRH director Jeffrey Shuren urges more medical device companies to join the Total Product Lifestyle Advisory Program.
Democratic leaders of the House Energy and Commerce Committee urge FDA to promptly issue the overdue draft guidance on drug and medical device clinica...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...
