title: User fees and beyond--the FDA Safety and Innovation Act of 2012.
authors.affiliation: Harvard Medical School, Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, USA.
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Kramer
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
mesh_terms: D002017:Budgets; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000191:economics* / Q000331:legislation & jurisprudence / Q000458:organization & administration; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence; D005249:Fees and Charges / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration / Q000191:economics / Q000331:legislation & jurisprudence / Q000458:organization & administration*