Category: News
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FDA Issues Final Order and Guidance on Surgical Staplers and Staples for Internal Use
New Class II designation for surgical staplers increases safety with stronger FDA review, oversight Today, the U.S. Food and Drug Administration announced several actions related to surgical stapler and staple regulation and safety. “At the heart of our public health mission is protecting the public by regulating medical devices to ensure they are safe to…
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FDA Announces Signing of Domestic Mutual Reliance Agreements with California, Florida, Utah and Wisconsin
Mutual Reliance Agreements The U.S. Food and Drug Administration today announced that California, Florida, Utah and Wisconsin have entered into domestic mutual reliance agreements with the agency. These Mutual Reliance agreements facilitate a coordinated effort between the FDA and individual states with goals to reduce human foodborne illness outbreaks, reduce duplication of regulatory oversight…
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FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs
Statement From:Donald D. Ashley, J.D. Director – Office of Compliance Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug. The FDA is continuing our efforts to help preserve access to compounded drugs for patients who have a medical need for them. We understand that compounded…
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NASA Sets Coverage, Invites Public to Virtually Join Lucy Launch
NASA will provide coverage of upcoming prelaunch and launch activities for Lucy, the agency’s first mission to explore the Jupiter Trojan asteroids. Lucy is scheduled to launch no earlier than 5:34 a.m. EDT Saturday, Oct. 16, on a United Launch Alliance (ULA) Atlas V 401 rocket from Space Launch Complex 41 at Cape Canaveral Space…
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NASA Announces Astronaut Changes for Upcoming Commercial Crew Missions
NASA has reassigned astronauts Nicole Mann and Josh Cassada to the agency’s SpaceX Crew-5 mission to the International Space Station as part of the Commercial Crew Program. Mann and Cassada will serve as spacecraft commander and pilot, respectively, for the Crew-5 mission. Additional crew members will be announced later. Crew-5 is expected…
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NASA, FEMA to Host Alliance for Climate Action Series in October
NASA and the Federal Emergency Management Agency (FEMA) will co-host the Alliances for Climate Action, a virtual series to address rising demand for accurate, timely, and actionable information at a time of rapid global climate change. The first event, featuring NASA Administrator Bill Nelson, will take place noon EDT Wednesday, Oct. 6, and will…
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FDA Authorizes Additional OTC Home Test to Increase Access to Rapid Testing for Consumers
The following is attributed to Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be…
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Are We Close to a Pill to Treat Covid? (video)
Scientist are racing to develop new tools to combat and treat COVID-19. One of those tools is an experimental pill to treat the pandemic. Merck is the first company to seek emergency us authorization from the FDA with its molnupiravir, an antiviral pill which, once approved, will become a valuable tool in the fight to…
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FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children
Today, the U.S. Food and Drug Administration is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines. VRBPAC Meeting on Janssen and Moderna COVID-19 Vaccine Boosters On Oct. 14 and 15, the advisory committee will meet to discuss the…
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NASA TV Coverage Set for Russian Film Production Launch
NASA will provide coverage of a Tuesday, Oct. 5 launch that will carry a Russian cosmonaut, actress, and film producer to the International Space Station, where they will film segments for a movie. The launch will mark the expansion of commercial space opportunities to include feature filmmaking. Film Producer Making his fourth flight into…