Use of a Computer in the New Drug Evaluation Process
The clinical reviewer for New Drug Applications (NDA) or Investigational New Drug Exemptions (IND’s) is faced with the sheer weight of the applications and NDA submissions have gone well above 1,000 volumes in size. Since each volume is about 500 pages long, this is about one half million pages to review.
KeywordsRapid Review Clinical Reviewer Review Officer Hard Copy Form Clinical Record Form
Unable to display preview. Download preview PDF.