The Food and Drug Administration's early access and fast-track approval initiatives: how have they worked?
Shulman
S R
SR
Tufts Center for the Study of Drug Development, Tufts University, Boston, MA, USA.
Brown
J S
JS
D017277:Drug Approval / Q000266:history* / Q000331:legislation & jurisprudence* / Q000379:methods; D004341:Drug Evaluation / Q000266:history / Q000331:legislation & jurisprudence / Q000379:methods; D015507:Drugs, Investigational / Q000627:therapeutic use; D049673:History, 20th Century; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence / Q000379:methods; D007880:Legislation, Drug / Q000266:history*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational