FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on September 21, 2021 - 18:16 GMT

FDA Authorizes Software that Can Help Identify Prostate Cancer

For Immediate Release: September 21, 2021 Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of areas that are suspicious for cancer as an …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 20, 2021 - 15:36 GMT

FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions

For Immediate Release: September 20, 2021 The U.S. Food and Drug Administration today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including …

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Published on September 20, 2021 - 14:57 GMT

FDA In Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs

For Immediate Release: September 20, 2021 The following quote is attributed to Theresa M. Michele, M.D., director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research “Over-the-counter (OTC) drugs continue to save …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2021 - 19:33 GMT

Coronavirus (COVID-19) Update: September 17, 2021

For Immediate Release: September 17, 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 Sept. 17, the FDA issued a Letter to Health Care Providers to alert …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2021 - 16:22 GMT

Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to ...

For Immediate Release: September 17, 2021 The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent injunction that prohibits a Florida-based company from producing or distributing any drugs until the company …

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Published on September 17, 2021 - 15:41 GMT

FDA In Brief: FDA Hosts Third Summit Focused on Reducing the Availability of Opioids Online

For Immediate Release: September 17, 2021 The following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D “The opioid crisis continues to be a national public health emergency with devastating and far-reaching consequences extending into …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 15, 2021 - 20:07 GMT

FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation

FDA News Release FDA prioritizes effective and efficient use of data by reorganizing IT, data and cybersecurity functions to agency-level For Immediate Release: September 15, 2021 Today, the U.S. Food and Drug Administration announced the reorganization of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 13, 2021 - 15:13 GMT

FDA In Brief: FDA Announces Winners of Food Traceability Challenge

For Immediate Release: September 13, 2021 The following quote is attributed to Frank Yiannas, Deputy Commissioner for Food Policy and Response “In June, we launched the New Era of Smarter Food Safety Low- or No-Cost Tech-enabled Traceability Challenge to …

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Published on September 12, 2021 - 11:15 GMT

Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds

For Immediate Release: December 09, 2021 Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 12, 2021 - 09:58 GMT

FDA Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak Responses

FDA Statement The following is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, and Stic Harris, D.V.M. director of the FDA’s Coordinated Outbreak Response and Evaluation Network For Immediate Release: December 09, 2021 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 10, 2021 - 19:50 GMT

Coronavirus (COVID-19) Update: September 10, 2021

For Immediate Release: September 10, 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 posted a statement titled “FDA Will Follow The Science On …

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Published on September 10, 2021 - 13:29 GMT

FDA Will Follow The Science On COVID-19 Vaccines For Young Children

FDA Statement The following is attributed to Acting FDA Commissioner Janet Woodcock M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Research and Evaluation For Immediate Release: September 10, 2021 Statement From: Janet …

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Published on September 9, 2021 - 19:12 GMT

FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 ...

For Immediate Release: September 09, 2021 Statement From: Janet Woodcock, M.D. Acting Commissioner of Food and Drugs - Food and Drug Administration The following is attributed to Acting FDA Commissioner Janet Woodcock, M.D., and Mitch Zeller, J.D., …

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Published on September 9, 2021 - 16:55 GMT

FDA, FTC Warn 10 Companies Illegally Selling Dietary Supplements Claiming to Treat Diabetes

For Immediate Release: September 09, 2021 Today, the U.S. Food and Drug Administration and the Federal Trade Commission posted warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent …

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Published on September 9, 2021 - 15:29 GMT

FDA In Brief: As Consumers Order More Meals and Groceries Online, FDA Plans Public Meeting to Address Food Safety Risks

For Immediate Release: September 09, 2021 The following quote is attributed to Frank Yiannas, Deputy Commissioner for Food Policy and Response “The COVID-19 pandemic has accelerated the need for the FDA to help ensure that foods ordered online and …

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Published on August 31, 2021 - 20:07 GMT

Coronavirus (COVID-19) Update: August 31, 2021

For Immediate Release: August 31, 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 August 27, the FDA made changes to the authorized use of the monoclonal …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 27, 2021 - 19:40 GMT

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

For Immediate Release: August 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: On August 25, the FDA issued a Letter to Health Care Providers alerting health …

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Published on August 27, 2021 - 15:20 GMT

FDA Approves First-of-Its-Kind Stroke Rehabilitation System

For Immediate Release: August 27, 2021 The U.S. Food and Drug Administration today approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 26, 2021 - 22:08 GMT

FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They ...

FDA News Release Action Marks First Marketing Denial Orders for E-Cigarette Products; Products Receiving Such Orders Must be Removed from the Market or Risk Enforcement; More Marketing Decisions to Follow For Immediate Release: August 26, 2021 Today, the U …

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Published on August 26, 2021 - 14:40 GMT

FDA Releases PFAS Testing Results from First Survey of Nationally Distributed Processed Foods

FDA News Release Nearly all foods tested had no detectable levels of PFAS; no evidence that levels found in samples indicate need to avoid particular foods For Immediate Release: August 26, 2021 Today, the U.S. Food and Drug Administration released the …

Distribution channels: Healthcare & Pharmaceuticals Industry