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911 articles found
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FDA Roundup: March 25, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA is issuing a 30-day procedural notice on the preliminary quantitative con... -
FDA Roundup: March 22, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On March 22, the FDA published a notice to clarify that the effectiveness of certain pro...
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FDA Statement on Medical Device User Fee Amendments (MDUFA)The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for the fifth reauthorization of the medical device user fee program. Under the new a...
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Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future BoostersToday, the U.S. Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Wed., April 6, to discuss considerations for...
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FDA Roundup: March 18, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On March 18, the FDA added the following frequently asked questions to the COVID-19 Test...
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FDA, Reagan-Udall Foundation to Hold Important Public Workshop to Discuss Naloxone AccessThe U.S. Food and Drug Administration will host a virtual public workshop on Mar. 29, to discuss critical questions around access to naloxone, a drug used to reverse opioid overdoses. The workshop is...
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FDA Roundup: March 15, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA is announcing the availability of two draft guidance documents: “Human Ge...
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FDA Approves First Generic of Symbicort to Treat Asthma and COPDToday, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health...
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FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety ReviewToday, the U.S. Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after...
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FDA Roundup: March 4, 2022Today, 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: “CDER Continues to Make Rare Diseases a Priorit...