SILVER SPRING, Md., July 28, 2023 /PRNewswire/ -- 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 Switzerlandentered 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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The "Europe
Welding Equipment Market-Growth, Trends, and Forecast (2019 - 2024)"
report has been added to ResearchAndMarkets.com's
offering.
Welding is one of the critical processes employed in the manufacturing...
Inovio Pharmaceuticals, Inc. announced today that its Ebola vaccine, INO-4201, was safe, tolerable, and generated strong T cell and antibody responses. This Phase 1 data was published in The Journal of Infectious Diseases and further supports the...
Merck , known as MSD outside the United States and Canada, and
NGM Biopharmaceuticals, Inc. (NGM) today announced that Merck has
exercised its option to extend the research phase of the companies'
broad, strategic collaboration...
The shareholders in Sandvik Aktiebolag are convened to the Annual General Meeting to be held on Monday, 29 April 2019 at 3:00 p.m. at the Göransson Arena, Sätragatan 21, Sandviken, Sweden.
RIGHT TO PARTICIPATE AND NOTICE
Shareholders who wish to...
The Oslo Business for Peace Award is given to inspiring business
leaders who have put society first.
2019's winners are: Dr Agbor Ashumanyi Ako,
medical director of GiftedMom, Alice Laugher, CEO of
Committed to...
The evolving competitive market has made it essential for the telecommunication industry to rethink traditional ways of doing business in terms of the impact on business models, service portfolios and technical architectures. Digital business support...