Pharmaceutical Regulatory Affairs: Open Access

Gauvin DV

Publications

• Review Article
  Schedule I Control Status Does Not Impede Legitimate Nonclinical Research in the United States
  Author(s): Gauvin DV and Zimmermann ZJGauvin DV and Zimmermann ZJ
  
  Background: There are many misconceptions about conducting research with Schedule 1 (CI) controlled substances to conduct nonclinical research in the US. Research design cannot be driven by financial constraints. Aim: The notion that current regulatory control of CI drugs hamper, hinders, or restricts legitimate nonclinical research in the U.S. may reflect a lack of understanding of the procedures in place to study these drugs. Review: Nonclinical research must comply with the Good Laboratory Practice (GLP) guidelines (21 CFR §58) of the U.S. Food & Drug Administration (FDA). Protocol development under the GLPs provides the information and details required under the Controlled Substances Act (CSA) for submission to the two drug regulating agencies relevant to the approvals required pr.. Read More»
  

  Abstract PDF