For Immediate Release: February 11, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Feb. 11, the U.S. Food and Drug Administration (FDA) opened the application portal for …
FDA Statement The following is attributed to Acting FDA Commissioner Janet Woodcock, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research For Immediate Release: February 11, 2022 Statement From: Janet …
For Immediate Release: February 11, 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. The EUA for …
For Immediate Release: November 02, 2022 Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s increased flexibilities. Company ( …
For Immediate Release: February 09, 2022 Today, the U.S. Food and Drug Administration took new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new …
For Immediate Release: September 02, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA published the FDA Voices: “Using A Whole-Of-Governments Approach to Combating …
For Immediate Release: February 08, 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 warned health care providers, parents and caregivers of pediatric patients (children) …
For Immediate Release: August 02, 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 announced the approval of the first generic firocoxib tablets for pain and …
For Immediate Release: June 02, 2022 Today, the U.S. Food and Drug Administration launched a new initiative, Supplement Your Knowledge, to help educate, inform, and broaden consumer, educator and healthcare professional understanding of dietary supplements …
For Immediate Release: June 02, 2022 Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities. Company …
For Immediate Release: February 04, 2022 Statement From: Janet Woodcock, M.D. Acting Commissioner of Food and Drugs - Food and Drug Administration Susan T. Mayne, Ph.D. Director - Center for Food Safety and Applied Nutrition (CFSAN) One of the U.S. Food …
For Immediate Release: February 04, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Feb. 3, the FDA issued a revised draft guidance for industry, “Assessment of Pressor Effects of …
For Immediate Release: February 02, 2022 The U.S. Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials (eye drops) to increase tear production in patients whose tear production is …
For Immediate Release: January 31, 2022 Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of …
For Immediate Release: January 28, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: As part of the FDA’s efforts to help ensure Americans have access to compounded medicines when a …
For Immediate Release: January 25, 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 issued two final guidances to provide recommendations for including patient perspectives …
FDA Statement The following is attributed to Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research For Immediate Release: January 24, 2022 Statement From: Patrizia Cavazzoni, M.D. Director - Center for Drug Evaluation and …
For Immediate Release: January 21, 2022 Today, the U.S. Food and Drug Administration took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to- …
For Immediate Release: January 21, 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 announced two FY 2022 funding opportunities that could provide up to $800,000 in support …
For Immediate Release: January 18, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: The CDRH Health of Women Program Strategic Plan is now available. CDRH initially issued a proposed …
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