Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review

Autor Pease, Alison M, Krumholz, Harlan M, Downing, Nicholas S, Aminawung, Jenerius A, Shah, Nilay D, Ross, Joseph S
Vydáno v BMJ (2017)

Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological st...

Autor Wallach, Joshua D., Ciani, Oriana, Pease, Alison M., Gonsalves, Gregg S., Krumholz, Harlan M., Taylor, Rod S., Ross, Joseph S.
Vydáno v BMC Med (2018)

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010

Autor Downing, Nicholas S., Shah, Nilay D., Aminawung, Jenerius A., Pease, Alison M., Zeitoun, Jean-David, Krumholz, Harlan M., Ross, Joseph S.
Vydáno v JAMA (2017)