Agri-Pulse

FDA proposes to extend compliance dates for ag water testing

The Food and Drug Administration plans to extend the compliance deadline for pre-harvest water testing requirements for produce other than sprouts, the agency said in a proposal that also extends the ...
Becker's Hospital Review

FDA denies exemption request for radiology AI devices

FDA denies exemption request for radiology AI devices, requiring continued 510(k) premarket review to ensure safety and effectiveness.
FiercePharma

FDA solicits feedback on controversial national priority voucher review pathway

Since its introduction nine months ago, the FDA’s national priority voucher pilot program has attracted intrigue and fierce criticism while also yielding several rapid drug approvals. With all of this ...
BioSpace

FDA flexibility isn’t absent but evolving regulations come with growing pains

The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare ...
FOX5 Las Vegas

FDA to phase out animal testing requirements

(CNN) - The Food and Drug Administration said it will phase out a requirement that certain drugs and monoclonal antibodies be tested on animals. In a statement, the FDA said it’s taking this step ...
The Hill

FDA says new regulations are needed to manage CBD risks

The Food and Drug Administration (FDA) on Thursday called for new regulations for the cannabidiol (CBD) market, saying the agency needs to provide additional oversight to manage the risks involved in ...
Hosted on MSN

FDA Removes REMS Requirements for CAR T Cell Therapies, Boosting Patient Access

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently announced it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) requirements for all currently approved BCMA- ...