IHS Markit | Outlook 2022: FDA to Finalize Food Traceability Rule, Work on Other FSMA-Related Priorities

This week, members of the House of Representatives elected Representative Mike Johnson (R-LA-4) as the new Speaker and the Health Resources and Services Administration (HRSA) issued a notice of registration requirements for off-site, outpatient hospital facilities to participate in the 340B Drug Pricing Program.

Our FDA and Health Care Policy teams discuss how sponsors and manufacturers can prepare for legislative and regulatory changes that could come from the final Food and Drug Amendments (PDUFA VII) and what companies can do today to leverage their current capabilities for success.

Sam Jockel comments on how the U.S. Food and Drug Administration’s revised definition of “healthy” could be a big change for the industry.

Sam Jockel comments on how the U.S. Food and Drug Administration’s revised definition of “healthy” could be a big change for the industry.

Just before the New Year holiday, the FDA announced it that was suspending non-mission-critical domestic and foreign inspection activities. The FDA amended the EUA of the Moderna COVID-19 vaccine booster. The Center for Drug Evaluation and Research released its annual report. This week, the Senate HELP Committee approved the nomination of Dr. Robert Califf for commissioner of the FDA. Senators introduced legislation that would require certain foreign establishments to register with the FDA. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.