For Immediate Release: October 15, 2021 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: On Oct. 12, the FDA posted information about an assessment of the Emergency Use Authorization ( …
For Immediate Release: October 14, 2021 Today, the U.S. Food and Drug Administration announced it has awarded 11 new clinical trial research grants, equaling more than $25 million of funding over the next four years. The FDA’s Congressionally-funded Orphan …
For Immediate Release: October 14, 2021 Today, the U.S. Food and Drug Administration is announcing an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback’s request for an emergency use authorization (EUA) …
FDA Statement The following is attributed to Acting FDA Commissioner Janet Woodcock, M.D., and Susan T. Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition For Immediate Release: October 13, 2021 Statement From: Janet Woodcock …
For Immediate Release: October 12, 2021 Today, the U.S. Food and Drug Administration announced it has authorized the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized …
For Immediate Release: October 12, 2021 The 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 announced that it intends to withdraw, effective Dec. 31, 2021 …
For Immediate Release: October 12, 2021 The following quote is attributed to Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research: “The FDA is committed to providing timely guidance to support continuity and response …
For Immediate Release: December 10, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On December 9, 2021, the FDA updated the SARS-CoV-2 Viral Mutations: Impact …
For Immediate Release: December 10, 2021 The following quote is attributed to William Maisel, M.D.,M.P.H., director of the Office of Product Evaluation and Quality and Ed Margerrison, Ph.D., director of the Office of Science and Engineering Laboratories, …
For Immediate Release: September 30, 2021 A study released today from the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention (CDC) estimated that more than 2 million U.S. middle and high school students reported …
For Immediate Release: September 30, 2021 Today, the U.S. Food and Drug Administration cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade. “Computed tomography is an important medical imaging tool …
For Immediate Release: September 29, 2021 The following quote is attributed to Thalia Mills, Ph.D., director, Division of Radiological Health, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiological Health “The FDA …
FDA News Release Today’s Activities Are Part of Ongoing Implementation of New Authorities for Certain Over-the-Counter Drugs For Immediate Release: September 24, 2021 The U.S. Food and Drug Administration today took steps aimed at improving the quality, …
For Immediate Release: September 22, 2021 Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months …
For Immediate Release: September 22, 2021 The following quote is attributed to Ed Margerrison, Ph.D., director of the Office of Science and Engineering Laboratories in the FDA’s Center for Devices and Radiological Health. “As part of the FDA’s ongoing …
For Immediate Release: September 22, 2021 Today, the U.S Food and Drug Administration issued for public comment two draft guidance documents that, if finalized, will help manufacturers of animal cells, tissues, and cell- and tissue-based products (ACTPs) …
For Immediate Release: September 21, 2021 Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of areas that are suspicious for cancer as an …
For Immediate Release: September 20, 2021 The U.S. Food and Drug Administration today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including …
For Immediate Release: September 20, 2021 The following quote is attributed to Theresa M. Michele, M.D., director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research “Over-the-counter (OTC) drugs continue to save …
For Immediate Release: September 17, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On Sept. 17, the FDA issued a Letter to Health Care Providers to alert …
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