FDA warns Professional Compounding Centers of America about CGMP deviations and violations and other violations in its production of compounded drugs.
FDA amends its guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency to add content about including p...
FDA acting commissioner Janet Woodcock says the agency is monitoring Covid-19 virus variants and considering a pathway for making changes to authorize...
Four stakeholder companies suggest changes to an FDA draft guidance on cross labeling oncology drugs in combination regimens.
FDA warns Chinas Yuyao Yijia Daily Chemical Co. about CGMP violations in its manufacturing of OTC drugs.
FDA accepts for priority review a Vertex Pharmaceuticals supplemental NDA to expand the use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacafto...
Myovant Sciences and Pfizer report positive data from the Phase 3 SPIRIT long-term extension study involving relugolix combination therapy in women wi...
FDA publishes a list of 105 proposed new and revised draft guidances to be issued by CDER in 2021.