For Immediate Release: March 26, 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 March 23, 2021, the FDA issued an emergency use authorization (EUA) to the …
For Immediate Release: March 26, 2021 Today, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), …
For Immediate Release: March 26, 2021 Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS). The device is …
For Immediate Release: March 25, 2021 Today, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic …
For Immediate Release: March 23, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: In a March 22 Consumer Update, the FDA provided an update on simple steps to …
FDA News Release Products Listing CBD as Inactive Ingredient Cited for Unapproved Drug and Misbranding Violations For Immediate Release: March 22, 2021 The U.S. Food and Drug Administration has issued warning letters to two companies for selling products …
FDA News Release Device may be used to identify biomarkers indicative of SARS-CoV-2 infection among certain asymptomatic individuals following a temperature reading that does not meet criteria for fever For Immediate Release: March 19, 2021 Today, the U.S. …
For Immediate Release: March 19, 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 March 16, the FDA posted a new web page on FDA.gov, Screening for COVID-19: …
FDA News Release BioFire Respiratory Panel 2.1 is the First COVID-19 Diagnostic Test Granted Marketing Authorization Using the De Novo Review Pathway For Immediate Release: March 17, 2021 Today, the U.S. Food and Drug Administration granted marketing …
For Immediate Release: March 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: On March 15, 2021, the FDA launched the COVID-19 EUA FDA Adverse Events …
FDA Statement The following is attributed to Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, and Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health …
For Immediate Release: March 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: As part of the FDA’s effort to protect consumers, the agency issued a warning …
For Immediate Release: December 03, 2021 Today, the U.S. Food and Drug Administration revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 …
For Immediate Release: November 03, 2021 The following quote is attributed to Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health “As technology continues to advance all facets of health care …
For Immediate Release: March 09, 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 Friday, the FDA issued an Emergency Use Authorization (EUA) to Cue Health …
For Immediate Release: August 03, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: In mid-July, the FDA held a stakeholder call to discuss COVID-19 vaccines, …
For Immediate Release: June 03, 2021 The following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance for FDA's Center for Drug Evaluation and Research “Ensuring the quality of prescription drugs and safeguarding the …
For Immediate Release: June 03, 2021 The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System due to a growing body of …
For Immediate Release: March 04, 2021 The U.S. Food and Drug Administration today alerted consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature—also known as telethermographic systems, …
For Immediate Release: March 05, 2021 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next generation sequencing based …
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