FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on March 24, 2023 - 14:44 GMT

FDA Works to Further Improve Nutrition, Reduce Diet-Related Chronic Disease with Dietary Guidance Statements on Food Labels

For Immediate Release: March 24, 2023 The U.S. Food and Drug Administration today issued draft guidance that provides food manufacturers with recommendations on how and when to use Dietary Guidance Statements on the label of food products to ensure the …

Distribution channels:

Published on March 24, 2023 - 13:50 GMT

FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval

For Immediate Release: March 24, 2023 Today, the U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 24, 2023 - 12:32 GMT

FDA Takes Additional Steps to Improve Nutrition, Reduce Disease with Expanded Use of Salt Substitutes to Help Lower Sodium Intake

For Immediate Release: March 24, 2023 Today, the U.S. Food and Drug Administration proposed changes to the standards of identity (SOIs) for foods that include salt to permit the use of safe and suitable salt substitutes. The proposed rule would help …

Distribution channels:

Published on March 21, 2023 - 19:43 GMT

FDA Roundup: March 21, 2023

For Immediate Release: March 21, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA completed its second pre-market consultation for a human food made from cultured animal …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 17, 2023 - 21:32 GMT

FDA Roundup: March 17, 2023

For Immediate Release: March 17, 2023 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 an emergency use authorization (EUA) for the Cue Mpox (Monkeypox) Molecular Test …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 17, 2023 - 15:05 GMT

FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette Products

FDA News Release Company Must Stop Marketing Unauthorized Products For Immediate Release: March 17, 2023 Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. …

Distribution channels:

Published on March 16, 2023 - 16:01 GMT

FDA Authorizes Copenhagen Classic Snuff to be Marketed as a Modified Risk Tobacco Product

FDA News Release Manufacturer Must Monitor Consumer Impact; FDA May Withdraw Authorization as Needed to Protect Public Health For Immediate Release: March 16, 2023 Today, the U.S. Food and Drug Administration authorized U.S. Smokeless Tobacco Company’s …

Distribution channels:

Published on March 14, 2023 - 20:43 GMT

Coronavirus (COVID-19) Update: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 ...

For Immediate Release: March 14, 2023 Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 14, 2023 - 19:00 GMT

FDA Roundup: March 14, 2023

For Immediate Release: March 14, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Yesterday, the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 11, 2023 - 15:05 GMT

FDA Roundup: November 3, 2023

For Immediate Release: November 03, 2023 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 announced that its Center for Devices and Radiological Health (CDRH) is seeking …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 10, 2023 - 20:59 GMT

FDA Roundup: March 10, 2023

For Immediate Release: March 10, 2023 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 notice addressing the agency’s COVID-19-related guidance documents, including …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 10, 2023 - 15:03 GMT

FDA Roundup: October 3, 2023

For Immediate Release: October 03, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA, in partnership with the University of Maryland Center of Excellence in Regulatory …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 10, 2023 - 14:56 GMT

FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants

For Immediate Release: October 03, 2023 Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 9, 2023 - 18:19 GMT

FDA Seeks $7.2 Billion to Protect and Advance Public Health by Enhancing Food Safety and Advancing Medical Product Availability

For Immediate Release: March 09, 2023 Today, the U.S. Food and Drug Administration announced it is requesting $7.2 billion as part of the president’s fiscal year (FY) 2024 budget. This funding will allow the agency to continue to leverage new and emerging …

Distribution channels:

Published on March 9, 2023 - 14:40 GMT

FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight

For Immediate Release: March 09, 2023 Today, the U.S. Food and Drug Administration published updates to the mammography regulations to, among other things, require mammography facilities to notify patients about the density of their breasts, strengthen the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 8, 2023 - 15:32 GMT

FDA Proposes New Requirements for Tobacco Product Manufacturing Practices

FDA News Release Agency Will Seek Input on the Proposed Rule from Both Its Advisory Committee and the Public For Immediate Release: March 08, 2023 Today, the U.S. Food and Drug Administration is proposing new requirements for tobacco product manufacturers …

Distribution channels:

Published on March 7, 2023 - 19:19 GMT

FDA Roundup: March 7, 2023

For Immediate Release: March 07, 2023 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 Letter to Health Care Providers about our expanded work to evaluate the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 5, 2023 - 13:01 GMT

FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine

FDA News Release Arexvy Approved for Individuals 60 Years of Age and Older For Immediate Release: May 03, 2023 Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 4, 2023 - 14:37 GMT

FDA Moves Forward with Mail-back Envelopes for Opioid Analgesics Dispensed in Outpatient Settings

FDA News Release Agency Continues to Take Steps to Reduce New Cases of Opioid Use Disorder For Immediate Release: April 03, 2023 Today, the U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 3, 2023 - 20:30 GMT

FDA Roundup: March 3, 2023

For Immediate Release: March 03, 2023 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 published the FDA Voices, “FDA and FTC Collaborate to Advance Competition in the …

Distribution channels: Healthcare & Pharmaceuticals Industry