FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a virtual meeting on June 28, 2022, to publicly discuss whether a change to the current vaccine strain composition of COVID-19…

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

This page lists Administrative Guidance documents.

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

MCMi regulatory science project to research issues that are key to understanding and predicting if—and how—vaccines and therapeutics to prevent and treat Ebola will show efficacy

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

Listing of cleared 510(k) submissions with supporting documents. Information is reflected as of the clearance date.

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)