FDA will hold a webinar regarding the proposed rule, which reiterates FDA’s assertion of jurisdiction over laboratory developed tests and proposes a phaseout of its general enforcement discretion approach.
On October 31,...more
The proposed rule, if finalized, would impose new manufacturing practice requirements on foreign and domestic manufacturers of finished and bulk tobacco products.
On March 10, 2023, the Food and Drug Administration (FDA...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
The legislation contains several reforms to FDA’s statutory authority and the regulatory framework that it administers.
Key Points:
..Omnibus legislation appropriates new funds to FDA and reauthorizes certain FDA...more
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