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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Medical Device User Fee Small Business Qualification and...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Five stakeholders make suggestions for changes to an FDA draft guidance on using real-world evidence in medical device regulatory decision-making.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.
Democratic leaders of the House Energy and Commerce Committee urge FDA to promptly issue the overdue draft guidance on drug and medical device clinica...
