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. These documents are frequently requested by the public through the Freedom of Information Act.
Product Approval Information
Biologics Products & Establishments Licensed Biological Products with Supporting Documents Substantially Equivalent 510(k) Device Information Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs) New Drug Applications (NDAs) Postmarketing Requirements and Commitments: Introduction Transfer of Therapeutic Products to the Center for Drug Evaluation and Research (CDER)
Compliance, Surveillance & Enforcement
Product Safety & Availability
Allergenic Products Advisory Committee Blood Products Advisory Committee Cellular, Tissue, and Gene Therapies Advisory Committee Transmissible Spongiform Encephalopathies Advisory Committee Vaccines and Related Biological Products Advisory Committee Workshops, Meetings & Conferences (Biologics) Transcripts & Minutes (Biologics)