For Immediate Release: July 26, 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 released new updates detailing the agency’s Cyclospora prevention and research efforts. …
For Immediate Release: July 22, 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 guidance for industry entitled “Failure to Respond to an ANDA Complete …
For Immediate Release: July 22, 2022 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration Judith A. McMeekin, Pharm.D. Associate Commissioner for Regulatory Affairs - Office of Regulatory Affairs The U. …
For Immediate Release: July 19, 2022 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration In February 2022, I rejoined the U.S. Food and Drug Administration as Commissioner of Food and Drugs, having …
For Immediate Release: July 19, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: The FDA updated the device shortage list and the device discontinuance list on the web page for Medical …
For Immediate Release: July 14, 2022 Today, the U.S. Food and Drug Administration announced the availability of educational resources for parents and caregivers with questions about using the hundreds of millions of bottles worth of imported infant formula …
For Immediate Release: July 13, 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome …
For Immediate Release: July 12, 2022 Today, the U.S. Food and Drug Administration (FDA) issued warning letters to four companies for illegally selling honey-based products that may pose a significant health risk to consumers. The FDA’s laboratory testing …
For Immediate Release: November 07, 2022 Statement From: Commissioner Dr. Robert M. Califf tested positive for COVID-19 over the weekend while traveling on official agency business. He is up to date on vaccines against COVID-19 and is experiencing mild …
For Immediate Release: October 07, 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 an Emergency Use Authorization (EUA) to Abbott Molecular, Inc., for the Alinity m …
For Immediate Release: October 07, 2022 Today, the U.S. Food and Drug Administration approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester of pregnancy to …
For Immediate Release: September 07, 2022 Today, the U.S. Food and Drug Administration is announcing steps to further increase monkeypox testing capacity and accessibility nationwide as part of its continued commitment to addressing the ongoing outbreak. …
For Immediate Release: July 08, 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: July 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 approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent Coronavirus …
For Immediate Release: June 30, 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 …
FDA Statement The following is attributed Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research For Immediate Release: June 30, 2022 Statement From: Peter Marks, M.D., PhD. Director - Center for Biologics Evaluation …
For Immediate Release: June 28, 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 and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months …
For Immediate Release: June 28, 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 …
FDA News Release Proposed rule is intended to increase options for the development of safe and effective nonprescription drugs For Immediate Release: June 27, 2022 Today, the U.S. Food and Drug Administration issued a proposed rule titled, “Nonprescription …
For Immediate Release: June 27, 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 …
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