On February 2, 2024, the U.S. Food and Drug Administration ("FDA") published a final rule1 to amend the current good manufacturing practice requirements.
The Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) are the two key statutes governing the development, manufacturing, distribution, registration, licensing, clearance.
On February 23, 2022, FDA published its long-awaited proposed rule1 to harmonize its regulations governing current good manufacturing practices ("cGMP") for.