FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on May 20, 2021 - 16:55 GMT

FDA In Brief: FDA Alerts Patients and Health Care Providers About Possible Problems with Mammograms Performed at Capitol Radiology ...

For Immediate Release: May 20, 2021 The following quote is attributed to David Lee, M.D., director, Division of Mammography Quality Standards, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiological Health “The FDA …

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Published on May 20, 2021 - 16:55 GMT

FDA In Brief: FDA Solicits Public Feedback on Discussion Paper as Part of its Ongoing Commitment to Patient Safety

For Immediate Release: May 20, 2021 The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health “The FDA continues to explore new approaches to promote greater safety of medical devices. Today, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 19, 2021 - 22:18 GMT

FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, ...

For Immediate Release: May 19, 2021 The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research Making COVID-19 vaccines widely available is key to getting people vaccinated and bringing …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 19, 2021 - 17:12 GMT

FDA In Brief: FDA Issues Draft Guidance on Early Clinical Studies for Certain Medical Devices to Improve Glycemic Control for Type ...

For Immediate Release: May 19, 2021 The following quote is attributed to Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health “As part of our commitment to help accelerate the development of innovative medical devices to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 19, 2021 - 16:27 GMT

FDA In Brief: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, ...

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

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 18, 2021 - 21:04 GMT

Coronavirus (COVID-19) Update: May 18, 2021

For Immediate Release: May 18, 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 May 17, the FDA provided summary information about the status of CytoDyn, Inc …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 18, 2021 - 15:28 GMT

FDA In Brief: Science Forum Highlights Regulatory Science Advancements in Protecting and Promoting Public Health

For Immediate Release: May 18, 2021 The following quote is attributed to FDA Chief Scientist Rear Adm. Denise Hinton “I am extremely proud of the hard work and dedication of our scientists, whose expertise and creativity enable us to develop the tools and …

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Published on May 17, 2021 - 14:51 GMT

FDA In Brief: FDA Provides Guidance on Master Protocols for Evaluating Prevention, Treatment Options for COVID-19

For Immediate Release: May 17, 2021 The following quote is attributed to Janet Woodcock, M.D., Acting FDA Commissioner “During this global pandemic, the FDA worked to protect the American public by using every tool at its disposal to quickly review and act …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 14, 2021 - 20:33 GMT

Coronavirus (COVID-19) Update: May 14, 2021

For Immediate Release: May 14, 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, on April 29, 2021 the agency …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 13, 2021 - 19:45 GMT

FDA In Brief: FDA Releases Investigation Report Following 2020 Salmonella Outbreak Linked to Red Onions

For Immediate Release: May 13, 2021 The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response “The FDA has been working with the CDC, state partners and Canadian officials to investigate the largest Salmonella …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 13, 2021 - 18:57 GMT

FDA In Brief: FDA Continues to Monitor the Effects of Magnets in Consumer Electronics on Implanted Medical Devices

For Immediate Release: May 13, 2021 The following quote is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health “Ensuring the safety of our nation’s medical devices is a cornerstone of our consumer …

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Published on May 11, 2021 - 21:28 GMT

Coronavirus (COVID-19) Update: May 11, 2021

For Immediate Release: May 11, 2021 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: As part of the FDA’s effort to protect consumers, on May 6, 2021, the agency issued a warning letter …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 11, 2021 - 16:01 GMT

Coronavirus (COVID-19) Update: November 5, 2021

For Immediate Release: November 05, 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. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 11, 2021 - 14:11 GMT

FDA In Brief: FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human ...

For Immediate Release: May 11, 2021 The following quote is attributed to Michael Kopcha Ph.D., R.Ph., director of the FDA’s Office of Pharmaceutical Quality “The FDA is continually working to promote drug innovation and improvement, strengthen quality …

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Published on May 10, 2021 - 21:38 GMT

Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another ...

For Immediate Release: May 10, 2021 Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 10, 2021 - 16:27 GMT

FDA In Brief: FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of ...

For Immediate Release: May 10, 2021 The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research “Vaccines continue to be an important public health measure in fighting the COVID-19 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 10, 2021 - 15:34 GMT

Coronavirus (COVID-19) Update: October 5, 2021

For Immediate Release: October 05, 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, on Sept. 28, the agency …

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Published on May 8, 2021 - 13:35 GMT

FDA In Brief: FDA Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact Containers

For Immediate Release: August 05, 2021 The following quote is attributed to Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition “The FDA is committed to ensuring that food containers are safe for consumers. We are encouraging …

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Published on May 7, 2021 - 20:02 GMT

Coronavirus (COVID-19) Update: May 7, 2021

For Immediate Release: May 07, 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, on May 6, 2021, the agency …

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Published on May 6, 2021 - 14:27 GMT

FDA In Brief: FDA Issues Procedural Notice on Potential Plans to Conduct Research About Use of ‘Healthy’ Symbols on Food Products

For Immediate Release: May 06, 2021 The following quote is attributed to Conrad Choiniere, Ph.D., director of the Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition "The FDA understands that consumers want healthy choices …

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