For Immediate Release: April 16, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: As part of the FDA’s effort to protect consumers, the agency issued a warning …
FDA News Release Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available For Immediate Release: April 16, 2021 Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that …
For Immediate Release: April 16, 2021 Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, …
For Immediate Release: April 14, 2021 The following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D. During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities that manufacture FDA-regulated …
Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and …
FDA Statement The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC For Immediate Release: April 13, 2021 Statement From: …
FDA Statement The following is attributed to Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health For Immediate Release: October 04, 2021 Statement From: Jeffrey E. Shuren, MD, JD Director - CDRH Offices: Office of the …
For Immediate Release: October 04, 2021 Today, the U.S. Food and Drug Administration issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information on the requirements for the content, …
FDA News Release Medical device aids clinicians in detecting potential irregularities during colon cancer screening and surveillance For Immediate Release: April 09, 2021 Today, the U.S. Food and Drug Administration authorized marketing of the GI Genius, …
For Immediate Release: April 09, 2021 The U.S. Food and Drug Administration (FDA), today, announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA issued a letter to health care personnel and facilities …
For Immediate Release: April 08, 2021 Statement From: Statement Author Leadership Role Acting Commissioner of Food and Drugs - Food and Drug Administration Janet Woodcock M.D. Leadership Role Director - Center for Food Safety and Applied Nutrition (CFSAN) …
For Immediate Release: August 04, 2021 Today, the U.S. Food and Drug Administration announced participation in several new collaborative communities aimed at addressing challenges in patient health care. Collaborative communities are a continuing forum …
For Immediate Release: April 06, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA issued an Emergency Use Authorization (EUA) to Symbiotica, Inc., for …
For Immediate Release: April 06, 2021 Statement From: Statement Author Leadership Role Deputy Commissioner for Food Policy and Response - Food and Drug Administration Frank Yiannas As part of our ongoing efforts to combat foodborne illness, today the U.S. …
For Immediate Release: April 06, 2021 The U.S. Food and Drug Administration today announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with …
For Immediate Release: June 04, 2021 Today, the U.S. Food and Drug Administration approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type 1, also referred to as hypoplasminogenemia, a disorder that can …
For Immediate Release: June 04, 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 June 1, the FDA approved an abbreviated new drug application for albuterol …
For Immediate Release: June 04, 2021 Today, the U.S. Food and Drug Administration approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition ( …
For Immediate Release: May 04, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA Center for Drug Evaluation and Research (CDER) continually monitors our …
For Immediate Release: March 30, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which …
