Related Experiment Video
Updated: Aug 21, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
Defending submission-year analyses of new drug approvals
Abstract:
In response to the critique of Mary Olsen, Daniel Carpenter, on behalf of his co-authors, addresses the issue of analysis based on the year a new drug is submitted for Food and Drug Administration (FDA) approval, not the year it is approved. Both substantive knowledge of the FDA drug review process and sound social science theory favor submission-year averaging. The history and bureaucratic mechanics of the Center for Drug Evaluation and Review (CDER) conform to the author's assumption. The statistical theory of optimal experimentation also points to the beginning of review as a locus for effects upon decisions.
Related Concept Videos
FDA Approved Drugs: Changes to Approved Drugs
Drug Regulation
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Clinical Trials: Overview
Drug Products: Biologics, Biosimilars and Interchangeables
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions