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
Life sciences companies seeking protection for their biological products gain clarity on the submission procedures and standards of evaluation for reference product exclusivity requests.
As the Food and Drug...more
What is new in the world of follow-on biologics?
Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more