title: Evidence vs. access: can twenty-first-century drug regulation refine the tradeoffs?
abstract: As the pharmaceutical industry productivity crisis worsens, there are calls for regulatory changes to support innovation. At the same time, prescribers and payers desire more information about drugs at the time they are released to the market. Will new regulatory schemes be able to accommodate these disparate needs?
authors.affiliation: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. janet.woodcock@fda.hhs.gov
authors.forename: J
authors.initials: J
authors.lastname: Woodcock
mesh_terms: D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods*; D006301:Health Services Needs and Demand / Q000331:legislation & jurisprudence* / Q000458:organization & administration*; D006801:Humans; D008004:Licensure / Q000331:legislation & jurisprudence*