Commentary Advocating That the FDA Disclose Information Related to Rejected or Withdrawn New Drug Applications
Read the full article here.
Public Citizen’s Health Research Group published a commentary in the Journal of Law, Medicine & Ethics advocating that the Food and Drug Administration (FDA) follow the lead of its European and Canadian counterpart agencies and: 1) notify the public when an application to market a new drug or new use for an already-marketed drug is rejected by the agency or withdrawn by the company; and 2) release its analyses of data submitted in support of such rejected or withdrawn applications.
View the article’s abstract here.
See Public Citizen’s other work on FDA transparency.