Potential pathways for abbreviated approval of generic biologics under existing law and proposed reforms to the law.
Dinh
Tam Q
TQ
Foley and Lardner, Washington, D.C., USA.
D001682:Biological Availability; D001688:Biological Products / Q000032:analysis / Q000191:economics / Q000493:pharmacokinetics / Q000627:therapeutic use; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence / Q000379:methods; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence; D016568:Drugs, Generic / Q000032:analysis / Q000191:economics / Q000493:pharmacokinetics / Q000627:therapeutic use; D015507:Drugs, Investigational / Q000191:economics / Q000493:pharmacokinetics / Q000633:toxicity; D006801:Humans; D017387:Investigational New Drug Application / Q000191:economics / Q000331:legislation & jurisprudence; D007880:Legislation, Drug / Q000191:economics; D008389:Marketing of Health Services / Q000191:economics / Q000331:legislation & jurisprudence; D010330:Patents as Topic / Q000331:legislation & jurisprudence; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
D001688:Biological Products; D016568:Drugs, Generic; D015507:Drugs, Investigational