FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on November 19, 2021 - 15:13 GMT

FDA In Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II

For Immediate Release: November 19, 2021 The following quote is attributed to Timothy Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health: “Today’s action allows …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2021 - 13:48 GMT

Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters

For Immediate Release: November 19, 2021 Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 16, 2021 - 21:29 GMT

FDA In Brief: FDA Announces Investigation of E. coli O157:H7 Outbreak Linked to Spinach

For Immediate Release: November 16, 2021 The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response: “The FDA, along with the CDC and our state and local partners, is working to investigate a multistate …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 16, 2021 - 19:57 GMT

Coronavirus (COVID-19) Update: November 16, 2021

For Immediate Release: November 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: Related Information ### Boilerplate The FDA, an agency within the U.S. …

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Published on November 16, 2021 - 18:28 GMT

FDA Authorizes Marketing of Virtual Reality System for Chronic Pain Reduction

For Immediate Release: November 16, 2021 The U.S. Food and Drug Administration today authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with …

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Published on November 15, 2021 - 15:24 GMT

Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access ...

FDA News Release Agency Details Test Priorities and Takes Steps Regarding the Appropriate Oversight of Tests For Immediate Release: November 15, 2021 Today, the U.S. Food and Drug Administration is taking several important actions to support ongoing …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 12, 2021 - 22:37 GMT

FDA Approves Treatment for Rare Blood Disease

FDA News Release Treatment is First FDA-Approved Option Patients Can Take Regardless of Previous Therapies For Immediate Release: November 12, 2021 Today, the U.S. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to …

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Published on November 12, 2021 - 21:43 GMT

FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

For Immediate Release: November 12, 2021 Today, the U.S. Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive …

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Published on November 12, 2021 - 20:49 GMT

Coronavirus (COVID-19) Update: November 12, 2021

For Immediate Release: November 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: On November 9, 2021, the FDA posted an updated Molecular and Antigen Home …

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Published on October 29, 2021 - 21:00 GMT

Coronavirus (COVID-19) Update: October 29, 2021

For Immediate Release: October 29, 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, October 22, 2021, Acting FDA Commissioner Janet Woodcock, M.D. and …

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Published on October 29, 2021 - 20:08 GMT

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

For Immediate Release: October 29, 2021 Español Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The …

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Published on October 27, 2021 - 20:43 GMT

FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases

For Immediate Release: October 27, 2021 The U.S. Food and Drug Administration, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies for the 30 million …

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Published on October 27, 2021 - 19:29 GMT

FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants

For Immediate Release: October 27, 2021 Today, the U.S. Food and Drug Administration took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. First, the agency …

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Published on October 27, 2021 - 15:29 GMT

FDA In Brief: FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice

For Immediate Release: October 27, 2021 The following quote is attributed to Bakul Patel, director of the FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health “With artificial intelligence and machine learning …

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Published on October 26, 2021 - 17:54 GMT

Coronavirus (COVID-19) Update: October 26, 2021

For Immediate Release: October 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: The FDA authorized the 10th over-the-counter (OTC) COVID-19 test, reissued …

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Published on October 25, 2021 - 16:00 GMT

FDA In Brief: FDA Makes Progress on Efforts to Understand Presence of Asbestos in Cosmetic Products

For Immediate Release: October 25, 2021 The following quote is attributed to Linda Katz, director of the FDA's Office of Cosmetics and Colors: “The FDA remains dedicated to keeping consumers safe from contaminated cosmetic products. As part of these …

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Published on October 22, 2021 - 19:51 GMT

Coronavirus (COVID-19) Update: October 22, 2021

For Immediate Release: October 22, 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 began posting materials for the next Vaccine and Related …

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Published on October 20, 2021 - 23:34 GMT

FDA In Brief: FDA Announces Investigation of Salmonella Outbreak Linked to Whole, Fresh Onions

For Immediate Release: October 20, 2021 The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response “The FDA, along with the CDC and our state and local partners, is working to investigate a multistate outbreak …

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Published on October 20, 2021 - 21:29 GMT

Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

For Immediate Release: October 20, 2021 Today, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 …

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Published on October 20, 2021 - 18:44 GMT

Federal judge enters consent decree with Utah-based dietary supplement manufacturer

For Immediate Release: October 20, 2021 A dietary supplement manufacturer and its two owners have been ordered by a federal court to stop selling products until they come into compliance with federal regulations and requirements under the Federal Food, …

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