FDA grants Better Therapeutics a breakthrough device designation for its Cognitive Behavioral Therapy platform that is intended to treat adults with m...
Federal Register notice: FDA makes available a final guidance entitled Assessing Covid19-Related Symptoms in Outpatient Adult and Adolescent Subjects ...
Federal Register notice: FDA debars Taylor McLaren for five years from importing or offering for import any drug into the U.S.
FDA accepts for review a Daiichi Sankyo and AstraZeneca BLA for datopotamab deruxtecan (Dato-DXd) for treating certain adult patients with locally adv...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Medical Device User Fee Small Business Qualification and...
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Five stakeholders make suggestions for changes to an FDA draft guidance on using real-world evidence in medical device regulatory decision-making.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.
