FDA Press Releases - EIN Presswire - Press Release Distribution Service

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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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Published on May 5, 2021 - 17:41 GMT

Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of ...

For Immediate Release: May 05, 2021 Today, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 30, 2021 - 21:39 GMT

Coronavirus (COVID-19) Update: April 30, 2021

For Immediate Release: April 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: On April 28, the FDA approved an abbreviated new drug application (ANDA) for 23 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 30, 2021 - 20:56 GMT

FDA Approves Treatment for Chronic Kidney Disease

FDA News Release Approval is First to Cover Many Causes of Disease For Immediate Release: April 30, 2021 Today, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 30, 2021 - 20:53 GMT

La FDA se compromete a tomar medidas basadas en la evidencia dirigidas a salvar vidas y prevenir futuras generaciones de fumadores

For Immediate Release: April 29, 2021 English Hoy, la Administración de Alimentos y Medicamentos de los EE.UU. (FDA, por sus siglas en inglés) anunció que se compromete a avanzar en el desarrollo de dos normas para productos del tabaco y reducir …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 30, 2021 - 13:45 GMT

FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose

For Immediate Release: April 30, 2021 The U.S. Food and Drug Administration announced today the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) of naloxone …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 29, 2021 - 14:22 GMT

FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers

For Immediate Release: April 29, 2021 Today, the U.S. Food and Drug Administration announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products, the leading cause of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 28, 2021 - 17:27 GMT

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov

For Immediate Release: April 28, 2021 Statement From: Statement Author Leadership Role Acting Commissioner of Food and Drugs - Food and Drug Administration Janet Woodcock M.D. Being transparent about the results of completed clinical trials enables …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 27, 2021 - 19:15 GMT

Coronavirus (COVID-19) Update: April 27, 2021

For Immediate Release: April 27, 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 …

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Published on April 23, 2021 - 23:08 GMT

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

FDA News Release Agencies Underscore Confidence in Vaccine’s Safety and Effectiveness Following Data Assessment; Available Data Suggest Potential Blood Clots Are Very Rare Events For Immediate Release: April 23, 2021 Following a thorough safety review, …

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Published on April 23, 2021 - 20:19 GMT

Coronavirus (COVID-19) Update: April 23, 2021

For Immediate Release: April 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: As part of the agency’s regulatory processes for reviewing all manufacturing …

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Published on April 23, 2021 - 15:22 GMT

FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients

For Immediate Release: April 23, 2021 Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or …

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Published on April 22, 2021 - 17:52 GMT

FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker

FDA News Release Approval is for recurrent or advanced mismatch repair deficient (dMMR) endometrial cancer For Immediate Release: April 22, 2021 Today, the U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for …

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Published on April 21, 2021 - 13:32 GMT

FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines

For Immediate Release: April 21, 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 Biologics Evaluation and Research (CBER) …

Distribution channels: Healthcare & Pharmaceuticals Industry