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Published on January 18, 2022 - 15:14 GMT

FDA Releases CDRH Health of Women Strategic Plan to Better Inform Medical Device Research and Regulation for All Women

FDA Statement The following is attributed to Terri Cornelison, M.D., Ph.D., Chief Medical Officer and Director, Health of Women Program at FDA Center for Devices and Radiological Health For Immediate Release: January 18, 2022 Statement From: Today, as part …

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Published on January 14, 2022 - 19:27 GMT

FDA Roundup: January 14, 2022

For Immediate Release: January 14, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the Interagency Food Safety Analytics Collaboration — a collaboration between the Centers for …

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Published on January 13, 2022 - 16:32 GMT

FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic ...

For Immediate Release: January 13, 2022 Today, the U.S. Food and Drug Administration released a white paper developed by the Interagency Working Group on Asbestos in Consumer Products (IWGACP) that contains scientific opinions for the testing of talc- …

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Published on January 13, 2022 - 15:50 GMT

FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal ...

For Immediate Release: January 13, 2022 Today, the U.S. Food and Drug Administration approved Solensia (frunevetmab injection), the first treatment for the control of pain associated with osteoarthritis in cats and the first monoclonal antibody (mAb) new …

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Published on January 11, 2022 - 22:28 GMT

FDA Roundup: January 11, 2022

For Immediate Release: January 11, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Jan. 10, the FDA announced in a letter of enforcement discretion that it does not intend to object …

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Published on January 11, 2022 - 16:55 GMT

FDA Roundup: November 1, 2022

For Immediate Release: November 01, 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 a proposed rule to amend the color additive regulations to increase the fees …

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Published on January 7, 2022 - 21:59 GMT

FDA Roundup: January 7, 2022

For Immediate Release: January 07, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Jan. 5, the FDA published a new, interactive public data dashboard that allows anyone to view …

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Published on January 7, 2022 - 14:33 GMT

Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months

For Immediate Release: January 07, 2022 Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster …

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Published on January 7, 2022 - 11:53 GMT

FDA Roundup: July 1, 2022

For Immediate Release: July 01, 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 a request for nominations for consumer representatives to serve on advisory …

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Published on January 5, 2022 - 00:26 GMT

FDA Roundup: January 4, 2022

For Immediate Release: January 04, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Dec. 21, the FDA published the webpage: Wastewater Surveillance for SARS-CoV-2 Variants describing …

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Published on January 4, 2022 - 15:11 GMT

FDA Roundup: April 1, 2022

For Immediate Release: April 01, 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 published the FDA Voices: “Give Your Community a Boost: Combatting Misinformation Through …

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Published on January 3, 2022 - 16:00 GMT

FDA Roundup: March 1, 2022

For Immediate Release: March 01, 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 a safety communication warning people not to use the Celltrion DiaTrust COVID-19 Ag …

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Published on January 3, 2022 - 14:51 GMT

Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

For Immediate Release: January 03, 2022 Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to: Expand the use of a single booster dose to include use in individuals 12 through …

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Published on January 3, 2022 - 10:55 GMT

FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments

FDA News Release FDA’s Industry Recommendations and Cancer Moonshot Aim to Improve Lives of Patients and Their Families For Immediate Release: March 01, 2022 Today, the U.S. Food and Drug Administration issued three final guidances to industry regarding …

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Published on January 2, 2022 - 16:38 GMT

Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 ...

For Immediate Release: February 01, 2022 Today, the U.S. Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the request for emergency use …

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Published on January 2, 2022 - 15:53 GMT

FDA Roundup: February 1, 2022

For Immediate Release: February 01, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Jan. 31, the FDA released a new video that provides an overview of the 2021 Food Allergy Safety, …

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Published on December 28, 2021 - 21:17 GMT

Coronavirus (COVID-19) Update: December 28, 2021

For Immediate Release: December 28, 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 Monday, the U.S. District Court for the District of New Jersey entered a …

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Published on December 23, 2021 - 17:47 GMT

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

For Immediate Release: December 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: On Wednesday, the FDA updated the SARS-CoV-2 Viral Mutations: Impact on …

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Published on December 23, 2021 - 14:57 GMT

Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults

For Immediate Release: December 23, 2021 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results …

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Published on December 23, 2021 - 14:16 GMT

FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them

For Immediate Release: December 23, 2021 Today, the U.S. Food and Drug Administration authorized the marketing of 22nd Century Group Inc.’s “VLN King” and “VLN Menthol King” combusted, filtered cigarettes as modified risk tobacco products (MRTPs), which …

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