title: Regulatory frameworks and decisions matter to the development of biotechnology and the approvals for biotechnology products.
authors.forename: G S
authors.initials: GS
authors.lastname: Omenn
mesh_terms: D001709:Biotechnology / Q000331:legislation & jurisprudence*; D018795:Device Approval / Q000331:legislation & jurisprudence; D014481:United States; D014484:United States Environmental Protection Agency; D014486:United States Food and Drug Administration