FDA Proposes to Modify Good Laboratory Practice Regulations, Broaden Application and Authority

In Depth

The proposed rule imposes heightened quality requirements for laboratory studies that are intended to support both product applications and other regulatory submissions that are not directly related to product approval. The proposal would also modify provisions for the care and handling of animals and expands requirements to encompass tobacco products. Comments are due by November 22, 2016.

Note: Since this On the Subject’s date of publication, FDA has extended the comment period from November 22, 2016 to January 21, 2017. See 81 Fed. Reg. 75,351 (Oct. 31, 2016).