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.