The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others.
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more
1/16/2023
/ Abbreviated New Drug Application (ANDA) ,
Biologics ,
Biosimilars ,
Cosmetics ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Inspections ,
Interchangeability ,
Manufacturing Facilities ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform
The Act reauthorizes FDA’s user fee programs but omits several proposed reforms to the FDA regulatory framework, setting the stage for further negotiations in Congress.
Key Points:
..Congress authorized FDA to...more