Regulatory Affairs Professionals Society

FDA proposes rule to ease registration for distributed manufacturers, require foreign API sites to register

The US Food and Drug Administration (FDA) on Friday outlined a set of proposed reforms to advance modern manufacturing ...
JD Supra

FDA Launches Green List To Simplify Import of Compliant GLP-1 API for Pharmacy Compounding

On Sept. 5, the FDA announced an import alert and green list for glucagon-like peptide-1 (GLP-1) active pharmaceutical ingredient (API) manufacturers. The FDA included manufacturers on the green list ...