News from u.s. food and drug administration A wide array of domestic and global news stories; news topics include politics/government, business, technology, religion, sports/entertainment, science/nature, and health/lifestyle.

11:58 ET New FDA Draft Guidance Aims to Increase Safety Information About Dietary Supplement Marketplace

Today, the U.S. Food and Drug Administration announced the availability of a draft guidance aimed at increasing the amount of safety information the...

May 18, 2022, 17:34 ET Actualización sobre el coronavirus (COVID-19): La FDA amplía la elegibilidad para la dosis de refuerzo de la vacuna contra el COVID-19 de Pfizer-BioNTech a niños de 5 a 11 años

May 18, 2022, 12:41 ET La FDA fomenta la importación segura de fórmula infantil y otras flexibilidades para aumentar su disponibilidad

May 17, 2022, 10:45 ET Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the...

May 16, 2022, 18:06 ET FDA Provides New Updates on Activities to Mitigate Infant Formula Supply Challenges, Abbott Nutrition Agrees to Take Corrective Actions at Facility to Produce Safe Infant Formula

The U.S. Food and Drug Administration is announcing important updates on its ongoing work to increase the supply and availability of infant formula...

May 16, 2022, 15:21 ET Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV

Today, the U.S. Food and Drug Administration authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription by...

May 13, 2022, 15:35 ET FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes

Today, the U.S. Food and Drug Administration approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes, ...

May 10, 2022, 17:32 ET FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products

Today, the U.S. Food and Drug Administration is providing an update on its work to increase the availability of infant and specialty formula products....

May 06, 2022, 17:41 ET Actualización sobre el coronavirus (COVID-19): La FDA limita el uso de la vacuna contra el COVID-19 de Janssen a determinadas personas

May 05, 2022, 18:48 ET La FDA emite cartas de advertencia a compañías que venden ilegalmente productos con CBD y Delta-8 THC

May 05, 2022, 17:26 ET Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older...

May 04, 2022, 16:08 ET FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer's Disease

The U.S. Food and Drug Administration today permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques...

May 04, 2022, 09:26 ET FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

Today, the U.S. Food and Drug Administration issued warning letters to five companies for selling products labeled as containing delta-8...

Apr 29, 2022, 14:22 ET La FDA propone normas que prohíben los cigarrillos mentolados y puros saborizados para prevenir la iniciación al tabaquismo en adolescentes y reducir significativamente la morbilidad y mortalidad relacionadas con el uso del tabaco

Apr 29, 2022, 09:58 ET Coronavirus (COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID-19 Vaccines

Today, the U.S. Food and Drug Administration is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products...

Apr 28, 2022, 12:00 ET FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death

Today, the U.S. Food and Drug Administration is announcing proposed product standards to prohibit menthol as a characterizing flavor in cigarettes...

Apr 27, 2022, 15:40 ET FDA Takes Steps to Limit Lead in Juice to Further Reduce Exposure to Toxic Elements in Foods

The U.S. Food and Drug Administration today issued draft action levels for lead in single-strength (ready to drink) apple juice and other...

Apr 26, 2022, 18:06 ET Actualización sobre el coronavirus (COVID-19): La FDA aprueba el primer tratamiento de COVID-19 para niños pequeños

Apr 26, 2022, 18:02 ET Actualización sobre el coronavirus (COVID-19): La FDA aprueba el primer tratamiento de COVID-19 para niños pequeños

Apr 25, 2022, 13:58 ET Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children

Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28...

Apr 20, 2022, 10:45 ET FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics, Decrease Unnecessary Exposure to Unused Medication

Today, the U.S. Food and Drug Administration announced it is seeking public comment on a potential change that would require opioid analgesics used...

Apr 19, 2022, 15:10 ET FDA Warns of Risks Associated with Non-Invasive Prenatal Screening Tests

Today, the U.S. Food and Drug Administration is warning the public of the risk of false results, inappropriate use and inappropriate interpretation...

Apr 18, 2022, 10:25 ET FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens

Today, the U.S. Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency's approach to evaluating the...

Apr 14, 2022, 17:25 ET Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical ...

Apr 13, 2022, 12:13 ET FDA Issues Final Guidance on Animal Drug Compounding from Bulk Drug Substances

Today, the U.S. Food and Drug Administration issued a final guidance, entitled "Compounding Animal Drugs from Bulk Drug Substances," that will help...