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FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments (RRA) Questions and Answers.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...
FDA tells Liquidia Corp. that its earlier user fee review action target date of 1/24 will be missed on the companys NDA for Yutrepia (treprostinil) in...
A Sheppard Mullin report describes several FDA issues that life sciences companies can expect to face in 2024.
