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Published on September 27, 2022 - 14:08 GMT

Coronavirus (COVID-19) Update: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for ...

For Immediate Release: September 27, 2022 Today, the U.S. Food and Drug Administration updated its COVID-19 test policy to ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket …

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Published on September 23, 2022 - 19:55 GMT

FDA Roundup: September 23, 2022

For Immediate Release: September 23, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “FDA Issues New Guidance to Help Facilitate Availability of …

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Published on September 23, 2022 - 14:26 GMT

New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials

For Immediate Release: September 23, 2022 Today, the U.S. Food and Drug Administration issued a draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical …

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Published on September 20, 2022 - 20:25 GMT

FDA Roundup: September 20, 2022

For Immediate Release: September 20, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA alerted medical device users about a potential cybersecurity risk for the Medtronic …

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Published on September 20, 2022 - 18:18 GMT

FDA Concludes Internal Review of Agency Actions Related to the U.S. Infant Formula Supply

For Immediate Release: September 20, 2022 Statement From: Steven M. Solomon, D.V.M., M.P.H. Director - Center for Veterinary Medicine In May 2022, FDA Commissioner Robert M. Califf, M.D., asked that I conduct an internal agency review of the agency’s …

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Published on September 20, 2022 - 18:18 GMT

FDA Committed to Strengthening U.S. Infant Formula Supply; Review Provides Roadmap to Support Ongoing Efforts

For Immediate Release: September 20, 2022 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration For the past several months, the U.S. Food and Drug Administration has been working around the clock with …

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Published on September 16, 2022 - 20:02 GMT

FDA Roundup: September 16, 2022

For Immediate Release: September 16, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, the FDA announced that it is taking steps to help increase the availability of novel …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 14, 2022 - 14:08 GMT

FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases

For Immediate Release: September 14, 2022 Today, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partnership aimed …

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Published on September 13, 2022 - 19:11 GMT

FDA Roundup: September 13, 2022

For Immediate Release: September 13, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA reissued the Aug. 19, 2022, letter of authorization for Novavax COVID-19 Vaccine, …

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Published on September 12, 2022 - 17:29 GMT

FDA Roundup: December 9, 2022

For Immediate Release: December 09, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA, in coordination with the U.S. Department of Agriculture and the Centers for Disease …

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Published on September 9, 2022 - 18:39 GMT

FDA Roundup: September 9, 2022

For Immediate Release: September 09, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted FAQs on Testing for Monkeypox with answers to frequently asked questions …

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Published on August 31, 2022 - 17:51 GMT

FDA Approves First Treatment for Acid Sphingomyelinase Deficiency, a Rare Genetic Disease

For Immediate Release: August 31, 2022 Today, the U.S. Food and Drug Administration approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disease that …

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Published on August 31, 2022 - 13:59 GMT

Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose

For Immediate Release: August 31, 2022 Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines …

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Published on August 30, 2022 - 19:22 GMT

FDA Roundup: August 30, 2022

For Immediate Release: August 30, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “FDA’s Overdose Prevention Framework Aims to Prevent Drug …

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Published on August 26, 2022 - 19:56 GMT

FDA Roundup: August 26, 2022

For Immediate Release: August 26, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, FDA provided additional guidance to help prescribers evaluate potential drug interactions when …

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Published on August 26, 2022 - 15:57 GMT

FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply

FDA News Release Agency Continues to Monitor Supply Chain to Help Ensure Continued Access For Immediate Release: August 26, 2022 Today, the U.S. Food and Drug Administration announced the removal of N95 respirators from the agency’s medical device shortage …

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Published on August 25, 2022 - 20:53 GMT

FDA and Mexican Counterparts Report Progress in Food Safety at Second Annual Partnership Meeting

For Immediate Release: August 25, 2022 Today, the U.S. Food and Drug Administration and its regulatory counterparts in Mexico – the Federal Commission for the Protection from Sanitary Risks (COFEPRIS) and the National Service of Agro-Alimentary Health, …

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Published on August 23, 2022 - 20:48 GMT

FDA Roundup: August 23, 2022

For Immediate Release: August 23, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA’s Office of Global Policy and Strategy posted an article about the FDA’s fruitful …

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Published on August 19, 2022 - 21:17 GMT

FDA Roundup: August 19, 2022

For Immediate Release: August 19, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for the prevention …

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Published on August 18, 2022 - 15:40 GMT

FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies

For Immediate Release: August 18, 2022 Today, the U.S. Food and Drug Administration issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type of product. These types of gummies are of particular public …

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