FDA Roundup: July 28, 2023

FDA News Release

• For Immediate Release: July 28, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Thursday, the FDA approved Ervebo, a vaccine for the prevention of Ebola virus disease caused by Zaire ebolavirus in individuals 12 months through 17 years of age. Ervebo has been approved for use in individuals 18 years of age and older since December 2019. Cases of Ebola are very rare in the U.S., and those that have occurred have been the result of infections acquired by individuals in other countries who then traveled to the U.S., or health care workers who became ill after treating patients with Ebola.
• On Thursday, the FDA’s Mutual Recognition Agreement with Switzerland entered into force, allowing the FDA and Swiss medical product regulatory authority, Swissmedic, to begin relying on each other’s factual findings from a good manufacturing practice inspection of a pharmaceutical manufacturing facility. 
• On Thursday, the FDA published “Catching Up with Califf:” “An Update on Sesame Allergen Labeling on Food Packages,” by Robert M. Califf, M.D., commissioner of Food and Drugs. Sesame was added as the ninth major food allergen earlier this year when the Food Allergy Safety, Treatment, Education, and Research Act went into effect. This means sesame is now required to be listed on food labels as a major allergen. The blog provides an update on the work underway to help sesame-allergic consumers find safe food options.
• On Thursday, the FDA announced the fiscal year (FY) 2024 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program, and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program. The user fee rates are authorized by the FDA Food Safety Modernization Act and allow the agency to assess and collect fees to cover the FDA’s cost of administering these programs. 
• On Wednesday, the FDA’s Center for Drug Evaluation and Research (CDER) issued final guidance for CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality, and launched a new portal to submit standards for potential recognition. Under this program, stakeholders can propose pharmaceutical quality standards for recognition by CDER, providing industry with additional resources for pharmaceutical development and manufacturing. In this CDER Conversation, Pallavi Nithyanandan, director of the Compendial Operations and Standards staff in CDER’s Office of Pharmaceutical Quality, outlines the program, explaining how stakeholders can participate and how the program may provide industry with additional resources for pharmaceutical development and manufacturing.