JD Supra

FDA’s AI White Paper: To Be or Not to Be, That is the Question

FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML). The white paper ...
JD Supra

FDA Posts Discussion Paper on Development of an Enhanced Systematic Process for Its Post-Market Assessment of Chemicals in Food; Comments Due December 6, 2024

As reported in our August 7, 2024, blog item, the U.S. Food and Drug Administration (FDA) announced on August 1, 2024, that it will hold a public meeting on September 25, 2024, on the development of ...
RAPS

FDA releases discussion paper on distributed and point-of-care manufacturing

The US Food and Drug Administration (FDA) has released a discussion paper on emerging and advanced manufacturing technologies concerning the distributed manufacturing (DM) and point-of-care (POC) ...
RAPS

How Many Drugs has FDA Approved in its Entire History? New Paper Explains

Pop quiz: While the US Food and Drug Administration (FDA) approves dozens of drugs each year, how many new drugs—i.e. discounting generic versions of approved drugs—has it approved in its entire ...
EurekAlert!

Schaeffer Center white paper outlines FDA reforms to boost pharmaceutical innovation and expand access

Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative gene therapies and advanced diagnostic tools. But significant policy and ...