The initiatives reflect the latest measures from federal agencies to reduce and ultimately replace animal testing in drug development and biomedical research....more
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
Drug Pricing Reform: President Biden, in remarks delivered on Sept. 27, 2022, touted insulin pricing provisions in H.R. 5376, the Inflation Reduction Act of 2022 (IRA), which became law on Aug. 16, 2022. He referred to...more
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
Agency signals forthcoming changes that could impact manufacturers’ ability to commercialize new medical devices.
Background -
On November 26, 2018, officials from the Food and Drug Administration (FDA or the Agency)...more