FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on August 1, 2020 - 01:30 GMT

FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic ...

For Immediate Release: July 31, 2020 Today, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 31, 2020 - 23:55 GMT

Coronavirus (COVID-19) Update: FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection

For Immediate Release: July 31, 2020 Today, the U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood. Both tests from Siemens, the ADVIA …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 31, 2020 - 21:38 GMT

Coronavirus (COVID-19) Update: Daily Roundup July 31, 2020

For Immediate Release: July 31, 2020 The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 31, 2020 - 14:52 GMT

FDA Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging

For Immediate Release: July 31, 2020 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Leadership Role Director - Center for Food Safety and Applied Nutrition (CFSAN) Susan T …

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Published on July 30, 2020 - 22:15 GMT

Coronavirus (COVID-19) Update: Daily Roundup July 30, 2020

For Immediate Release: July 30, 2020 The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: The FDA, an agency within the U.S. Department of Health and Human Services, protects the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 30, 2020 - 19:54 GMT

FDA Announces New Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water

FDA News Release The EPA-approved protocol can be used to evaluate the effectiveness of treatments in reducing microbial contamination in agricultural water For Immediate Release: July 30, 2020 Today, the U.S. Food and Drug Administration announced a new …

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Published on July 29, 2020 - 23:49 GMT

FDA Warns Companies Illegally Selling Hangover Remedies

For Immediate Release: July 29, 2020 Today, the U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or …

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Published on July 29, 2020 - 22:09 GMT

Coronavirus (COVID-19) Update: Daily Roundup July 29, 2020

For Immediate Release: July 29, 2020 The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: On July 28, the FDA updated the Molecular Diagnostic templates. The Molecular Diagnostic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 29, 2020 - 17:23 GMT

Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab ...

For Immediate Release: July 29, 2020 Today, the U.S. Food and Drug Administration posted a new template for commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 28, 2020 - 21:17 GMT

Coronavirus (COVID-19) Update: Daily Roundup July 28, 2020

For Immediate Release: July 28, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Today, FDA posted the audio and transcript versions of Episode 6 in its new …

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Published on July 27, 2020 - 22:09 GMT

Coronavirus (COVID-19) Update: Daily Roundup July 27, 2020

For Immediate Release: July 27, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On July 24, the FDA reissued the LabCorp COVID-19 RT-PCR Test emergency use …

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Published on July 27, 2020 - 17:06 GMT

Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes ...

For Immediate Release: July 27, 2020 The U.S. Food and Drug Administration continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 25, 2020 - 01:28 GMT

Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 ...

FDA News Release Authorization is also second to allow testing of pooled samples For Immediate Release: July 24, 2020 Today, the U.S. Food and Drug Administration reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 24, 2020 - 21:44 GMT

Coronavirus (COVID-19) Update: Daily Roundup July 24, 2020

For Immediate Release: July 24, 2020 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, an agency within the U.S. Department of Health and Human Services, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 24, 2020 - 19:30 GMT

FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL

For Immediate Release: July 24, 2020 Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to …

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Published on July 23, 2020 - 21:31 GMT

Coronavirus (COVID-19) Update: Daily Roundup July 23, 2020

For Immediate Release: July 23, 2020 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 updated the Testing Supply Substitution Strategies slide show. …

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Published on July 23, 2020 - 20:00 GMT

FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone

FDA News Release Goal is to Help Reduce Opioid Overdoses and Deaths For Immediate Release: July 23, 2020 The U.S. Food and Drug Administration today announced it is requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 23, 2020 - 14:54 GMT

FDA Proposes New Rule on Reporting Requirements

For Immediate Release: July 23, 2020 Today, the U.S. Food and Drug Administration published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that when finalized, will implement a statutory requirement for sponsors and …

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Published on July 22, 2020 - 23:23 GMT

Coronavirus (COVID-19) Update: Daily Roundup July 22, 2020

For Immediate Release: July 22, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: FDA created a new website section about COVID-19 for people with cancer and …

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Published on July 21, 2020 - 22:35 GMT

Coronavirus (COVID-19) Update: Daily Roundup July 21, 2020

For Immediate Release: July 21, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: A new FDA Voices, tilted FDA’s Ongoing Work to Support and Advance COVID-19 …

Distribution channels: Healthcare & Pharmaceuticals Industry