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Biologics Documents

Biologic products are approved and regulated by FDA's Center for Biologics Evaluation and Research (CBER). Information available under FOIA regarding biologics closely follows that for drugs and devices. For drug-like products, a Summary Basis of Approval (SBOA) is prepared, generally within six months of approval, and is available along with the approval letter, package insert, and labeling. For device-like products (usually diagnostics), a biologic 510(k) is available, again generally six months after permission to enter the market is granted. As with other FDA-regulated products, information about items undergoing FDA review is not disclosable.

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