HBW Insight, Rose Sheet | US FDA Priorities for Food Safety, Cannabidiod Clear Even with Next Commissioner Unknown

Our FDA/Food, Drug & Device Team examines how the Food and Drug Administration is approaching the preclearance and approval process for artificial intelligence (AI) and machine learning (ML) components in products under its purview.

This week, President Biden signed a “laddered” continuing resolution, averting a government shutdown, and the House Energy & Commerce Health Subcommittee advanced 21 healthcare bills to the full Committee.

The House has no votes scheduled this week, but the Senate must pass a continuing resolution before Friday to prevent a government shutdown. The upper chamber will also vote on more of President Biden’s nominees and a package of changes to the U.S. Postal Service. 

OSHA withdrew its emergency temporary standard, which required a mandatory vaccination policy for large private employers. The FDA extended its pause on non-mission-critical domestic surveillance inspections to February 4, and the Biden Administration announced that it was making at-home test kits available to the American public. Robert Califf previewed his priorities, if confirmed as commissioner of the FDA, to the Senate HELP Committee. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.

In the past week, the President has selected Dr. Robert Califf to be FDA commissioner. Congress passed the Infrastructure Investment and Jobs Act. New vaccination requirements were issued by OSHA and CMS for certain employers. Also, the State Department updated its rules for passengers entering the United States. Please see details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.