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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

The Host Julie Rovner KFF Health News @jrovner Read Julie’s stories. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health…

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.

SACRAMENTO — A judge has initiated a federal court takeover of California’s troubled prison mental health system by naming the former head of the Federal…

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