A Skadden Insights post raises the concern of FDA-regulated companies caused by the significant leadership changes at the agency.
FDA warns Canada’s Jubilant HollisterStier General Partnership about CGMP violations in its manufacturing of finished drugs.
A Skadden Insights post raises the concern of FDA-regulated companies caused by the significant leadership changes at the agency.
FDA warns Canada’s Jubilant HollisterStier General Partnership about CGMP violations in its manufacturing of finished drugs.
Former FDA commissioner Scott Gottlieb supports the agency's newly announced initiative to accelerate early-stage clinical trials, arguing that the package of reforms could help reverse the migration of Phase 1 studies to overseas markets.
FDA closes a potential enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about whether the company's Blood Pressure Insights feature should be regulated as a medical device.
