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911 articles found
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FDA Announces Additional Steps to Modernize Clinical TrialsToday, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and cond... -
FDA Roundup: June 6, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA issued a Letter to Health Care Providers recommending health care fa...
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FDA Roundup: June 2, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA provided an update on medical device reports it received that are report...
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FDA Conducts Retailer Inspection Blitz, Cracks Down on Illegal Sales of Popular Disposable E-cigarettesToday, the U.S. Food and Drug Administration issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products. The unauthorized products were vari...
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FDA Proposes New, Easy-to-Read Medication Guide for Patients, Patient Medication InformationProviding people with accurate and timely information to help them take their prescription medications safely and effectively is an important priority for the U.S. Food and Drug Administration. Eviden...
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FDA Roundup: May 30, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA issued the Adjusting for Covariates in Randomized Clinical Trials fo...
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FDA Roundup: May 26, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued warning letters to firms responsible for two popular flavor...
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FDA Approves First Oral Antiviral for Treatment of COVID-19 in AdultsToday, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19...
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FDA Approves New Buprenorphine Treatment Option for Opioid Use DisorderToday, the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD). Br...
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FDA Roundup: May 23, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA and the Veterans Health Administration announced a new collaboration...