title: Demystifying the U.S. Food and Drug Administration: I. Understanding agency structure and function.
abstract: The U.S. Food and Drug Administration is the government agency responsible for oversight of the safety and efficacy of pharmaceuticals and devices, including biologics and devices that combine biologics with other materials. Within the U.S. Food and Drug Administration, the Center for Biologics Evaluation and Research is specifically responsible for the evaluation and approval of biological products. This department of the U.S. Food and Drug Administration has a series of mechanisms in place to aid researchers in the process of developing new biologics. This article outlines the study phases involved in developing new biologics and how the Center for Biologics Evaluation and Research and investigators can work together to facilitate this process. It also discusses issues specific to biologics that have been encountered in the past and that investigators should consider when developing and obtaining approval for new biologics. The equivalent center within the U.S. Food and Drug Administration for approving medical devices is the Center for Devices and Radiological Health. The equivalent process of development and approval of medical devices is similarly discussed. Finally, essential contacts for investigators within the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health are provided.
authors.affiliation: From the Division of Plastic Surgery and Burn Surgery, Burn/Wound and Regenerative Medicine Laboratory, University of Michigan; the University of Michigan; Department of Plastic Surgery, University of Pittsburgh; Division of Plastic Surgery, Department of Surgery, Mount Sinai Hospital; The Plastic Surgery Foundation of the American Society of Plastic Surgeons; Health Policy and Advocacy Division, American Society of Plastic Surgeons; and Department of Surgery, University of Michigan.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Levi
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Lisiecki
authors.forename: Peter
authors.initials: P
authors.lastname: Rubin
authors.forename: Richard A
authors.initials: RA
authors.lastname: D'Amico
authors.forename: Keith M
authors.initials: KM
authors.lastname: Hume
authors.forename: Bill
authors.initials: B
authors.lastname: Seward
authors.forename: Paul S
authors.initials: PS
authors.lastname: Cederna
mesh_terms: D001688:Biological Products; D064987:Cell- and Tissue-Based Therapy; D003094:Collagen; D018795:Device Approval; D006801:Humans; D017768:Skin, Artificial; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*
chemical_list: C117898:Apligraf; D001688:Biological Products; D003094:Collagen