FDA issues a guidance entitled Human Gene Therapy Products Incorporating Human Genome Editing.
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...
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FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments (RRA) Questions and Answers.
