Food and Drug Administration

Today, the FDA approved the first COVID-19 treatment for children less than 12 years of age.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

The U.S Food and Drug Administration established a public docket to consider adding a mail-back envelope requirement to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that all opioid analgesics, including immediate-release, extended-release, and long-acting formulations, use

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Today, the FDA is warning the public of the risk of false results, inappropriate use and inappropriate interpretation of results with non-invasive prenatal screening tests, also called cell-free DNA tests or non-invasive prenatal tests.

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

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 for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.

FDA issued a final guidance that will help protect animal health by addressing need for access to certain compounded animal drugs.

The FDA issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials – expanding on the agency’s previous guidances for industry to improve clinical trial diversity.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

The U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration have issued joint warning letters to two online sellers of illegal versions of Schedule II stimulants (including amphetamines marketed illicitly as Adderall) that are not FDA approved.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

The FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals.

A raw animal food manufacturer has been ordered to stop selling products until they come into compliance under the Federal Food, Drug, and Cosmetic Act

FDA is announcing it is requesting a total budget of $8.4 billion as part of the President’s fiscal year 2023 budget for investments in critical public health modernization, core food safety and medical product safety programs.