Satellite laboratories stationed inside high-volume international mail facilities at airports in Chicago, New York, Los Angeles, Miami—and now Honolulu—are one of the U.S. Food and Drug Administration’s numerous weapons in combating counterfeit and other potentially harmful drugs.
Read More

---

This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.
Read More

---

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) September 20, 2024 Meeting announcement and meeting materials.
Read More

---

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
Read More

---

Latest news from the Center for Biologics Evaluation and Research
Read More

---

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 150,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.
Read More

---

The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.
Read More

---

This is the draft guidance for industry, Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing
Read More

---

The U.S. Food and Drug Administration today issued a draft guidance for sponsors seeking approval of human gene therapy products involving genome editing technologies.
Read More

---

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

---

This page contains a listing of cellular and gene therapy guidances.
Read More

---

Description of CBER's Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions.
Read More

---