FDA grants Google a de novo marketing authorization for its new body temperature app on its latest Pixel 8 Pro smart phone.
FDA releases a document entitled Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products.
A new GAO reports recommends that FDA identify and document specific changes to its statutory authorities that would enable it to best oversee artific...
The International Council for Harmonization releases a guidance entitled Q14 Guideline on Analytical Procedure Development.
FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments (RRA) Questions and Answers.
Federal Register notice: FDA announces the renewal of its Vaccines and Related Biological Products Advisory Committee for an additional two years.
Azurity Pharmaceuticals recalls one lot of narcolepsy drug Zenzedi CII (dextroamphetamine sulfate tablets, USP) 30 mg after a report was received that...
Merck says data from its Phase 3 AMBASSADOR (A031501)/KEYNOTE-123 trial evaluating Keytruda (pembrolizumab) are favorable for the therapy as a potenti...
