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911 articles found
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Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-OldsToday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to... -
FDA Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak ResponsesThe U.S. Food and Drug Administration has a longstanding commitment to strengthening food safety and better protecting consumers, as part of its public health agenda. Today, we are taking an important...
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Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain IndividualsToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-expo...
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Coronavirus (COVID-19) Update: December 7, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVI...
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FDA In Brief: FDA Takes New Steps Aimed at Advancing Development of Individualized Medicines to Treat Genetic DiseasesThe following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D. “Progress in individualized medicines provides hope to patients with severely debilitating or life-threaten...
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FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including NewbornsToday, the U.S. Food and Drug Administration revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighi...
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FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on ProduceToday, the U.S. Food and Drug Administration issued a proposed rule that aims to enhance the safety of produce. It proposes to require farms to conduct comprehensive assessments that would help them i...
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Coronavirus (COVID-19) Update: November 30, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Today, the FDA issued a statement that it is actively working...
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Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and BoostersAs we have with previous emerging COVID-19 variants, the U.S. Food and Drug Administration is actively working with our federal partners, international regulators and medical product companies to quic...
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FDA Approves New Imaging Drug to Help Identify Ovarian Cancer LesionsThe U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the abi...