Medical Device Legal News with Sam Bernstein: Episode 11
On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more
The US Environmental Protection Agency’s (EPA) Office of Environmental Justice (OEJ) and External Civil Rights Compliance Office issued draft guidance (Draft Guidance) on June 2, 2022, outlining how EPA intends to integrate...more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more