FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on April 25, 2022 - 18:19 GMT

Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children

For Immediate Release: April 25, 2022 Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 22, 2022 - 19:58 GMT

FDA Roundup: April 22, 2022

For Immediate Release: April 22, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Thursday, the FDA announced the availability of a draft guidance on FDA’s policy regarding products …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 20, 2022 - 14:35 GMT

FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics, Decrease Unnecessary Exposure to Unused ...

For Immediate Release: April 20, 2022 Today, the U.S. Food and Drug Administration announced it is seeking public comment on a potential change that would require opioid analgesics used in outpatient settings to be dispensed with prepaid mail-back …

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Published on April 19, 2022 - 20:43 GMT

FDA Roundup: April 19, 2022

For Immediate Release: April 19, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued its final rule titled "Beverages: Bottled Water". This final rule amends …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 19, 2022 - 19:42 GMT

FDA Warns of Risks Associated with Non-Invasive Prenatal Screening Tests

FDA News Release Inappropriate interpretation of results may lead to potentially improper medical decisions For Immediate Release: April 19, 2022 Today, the U.S. Food and Drug Administration is warning the public of the risk of false results, inappropriate …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 18, 2022 - 14:19 GMT

FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens

For Immediate Release: April 18, 2022 Today, the U.S. Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major …

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Published on April 15, 2022 - 20:36 GMT

FDA Roundup: April 15, 2022

For Immediate Release: April 15, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On April 14, the FDA issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 14, 2022 - 21:03 GMT

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

FDA News Release Test provides results in less than three minutes For Immediate Release: April 14, 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 13, 2022 - 20:08 GMT

FDA Issues Final Guidance on Animal Drug Compounding from Bulk Drug Substances

FDA News Release Agency Planning Outreach and Education Period as Part of Implementation For Immediate Release: April 13, 2022 Today, the U.S. Food and Drug Administration issued a final guidance, entitled “Compounding Animal Drugs from Bulk Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 13, 2022 - 14:23 GMT

FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials

FDA News Release Agency’s Focus on Inclusion in Trials for All Medical Products Aligns with Biden Administration’s Cancer Moonshot Goal of Addressing Inequities and Beyond For Immediate Release: April 13, 2022 Today, the U.S. Food and Drug Administration …

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Published on April 12, 2022 - 20:10 GMT

FDA Roundup: April 12, 2022

For Immediate Release: April 12, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On April 8, the FDA cleared Fitbit’s Irregular Rhythm Notifications software intended to be used with …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 12, 2022 - 15:59 GMT

FDA and DEA Warn Online Pharmacies Illegally Selling Adderall to Consumers

FDA News Release Agency Committed to Using All Available Tools to Stop Online Businesses Illegally Selling Potentially Harmful Drug Products to Consumers For Immediate Release: April 12, 2022 The U.S. Food and Drug Administration and the U.S. Drug …

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Published on April 11, 2022 - 17:51 GMT

FDA Roundup: November 4, 2022

For Immediate Release: November 04, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued a safety communication warning parents, caregivers, and health care …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 10, 2022 - 15:19 GMT

FDA Roundup: October 4, 2022

For Immediate Release: October 04, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted a Constituent Update, highlighting that in September, the FDA and CDC signed a …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 9, 2022 - 00:02 GMT

FDA Roundup: April 8, 2022

For Immediate Release: April 08, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On April 7, the FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 …

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Published on April 8, 2022 - 20:50 GMT

Joint Statement from CMS Administrator Chiquita Brooks-LaSure and FDA Commissioner Robert M. Califf, M.D., on Ensuring Access to ...

For Immediate Release: April 08, 2022 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration Ensuring the availability of innovative interventions for people is a shared priority for both the Centers for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 5, 2022 - 20:27 GMT

FDA Roundup: April 5, 2022

For Immediate Release: April 05, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to …

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Published on April 5, 2022 - 14:36 GMT

FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease

For Immediate Release: May 04, 2022 The U.S. Food and Drug Administration today permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease. The Lumipulse G β-Amyloid Ratio (1-42/1- …

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Published on April 5, 2022 - 08:40 GMT

FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

For Immediate Release: May 04, 2022 Today, the U.S. Food and Drug Administration issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and …

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Published on March 29, 2022 - 21:58 GMT

FDA Roundup: March 29, 2022

For Immediate Release: March 29, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA authorized a manufacturing change for the Moderna COVID-19 Vaccine to include an …

Distribution channels: Healthcare & Pharmaceuticals Industry