Disqualification of a Clinical Investigator (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
The Law Library presents the complete text of the Disqualification of a Clinical Investigator (US Food and Drug Administration Regulation) (FDA) (2018 Edition).
Updated as of May 29, 2018
The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
This book contains:
- The complete text of the Disqualification of a Clinical Investigator (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A table of contents with the page number of each section
