FDA announces a 10/21-10/22 virtual workshop on fetal pharmacology and therapeutics.
FDA publishes an International Council on Harmonization addendum expanding testing methods for human carcinogenicity risk studies.
FDA warns The Medicine Shoppe in Port Charlotte, FL, that it is producing compounded drugs that dont meet legal requirements and dont comply with CGMP...
FDA medical reviewers raise issues with two trials of Takedas maribavir to treat cytomegalovirus.
Takeda Pharmaceutical Co. stops two Phase 2 studies of TAK-994, an investigational oral orexin agonist for treating narcolepsy, after a unexpected sa...
Federal Register notice: FDA makes available a guidance entitled #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Dr...
FDA publishes four final guidances encouraging new sponsors of new animal drugs to pursue innovative ways to prepare and submit data for FDA evaluatio...
Federal Register notice: FDA makes available a draft guidance entitled S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals.