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Azurity Pharmaceuticals recalls one lot of narcolepsy drug Zenzedi CII (dextroamphetamine sulfate tablets, USP) 30 mg after a repo...[ Price : $8.95]
Merck says data from its Phase 3 AMBASSADOR (A031501)/KEYNOTE-123 trial evaluating Keytruda (pembrolizumab) are favorable for the ...[ Price : $8.95]
FDA grants Google a de novo marketing authorization for its new body temperature app on its latest Pixel 8 Pro smart phone.[ Price : $8.95]
FDA releases a document entitled Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biologica...[ Price : $8.95]
A new GAO reports recommends that FDA identify and document specific changes to its statutory authorities that would enable it to ...[ Price : $8.95]
The International Council for Harmonization releases a guidance entitled Q14 Guideline on Analytical Procedure Development.[ Price : $8.95]
FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments (RRA) Questions and Answers.[ Price : $8.95]
Federal Register notice: FDA announces the renewal of its Vaccines and Related Biological Products Advisory Committee for an addit...