Zdrowie i gospodarka · 16/02/1996
Disqualification of a Clinical Investigator
The Food and Drug Administration (FDA) is proposing to amend the investigational new drug regulation that provides for disqualification of clinical investigators for submitting false information. It has come to the agency's attention that, as written, the regulation may be unclear. The proposed amendment would clarify the agency's authority to reach sponsor-investigators under the existing regulation.