title: [Off-label use of drugs--the legal framework].
authors.affiliation: Rechtsanwaltskanzlei Mayer Brown LLP, Düsseldorf. akoyuncu@mayerbrown.com
authors.forename: A
authors.initials: A
authors.lastname: Koyuncu
mesh_terms: D057176:Compassionate Use Trials / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence; D005858:Germany; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D019458:Insurance Coverage / Q000331:legislation & jurisprudence; D007356:Insurance, Pharmaceutical Services / Q000331:legislation & jurisprudence; D008318:Malpractice / Q000331:legislation & jurisprudence; D009313:National Health Programs / Q000331:legislation & jurisprudence*; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D018570:Risk Assessment