HHS - 21 CFR PART 54
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
active, Most Current
| Organization: | HHS |
| Publication Date: | 1 April 2021 |
| Status: | active |
| Page Count: | 5 |
scope:
The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for making the appropriate certification or disclosure statement where the applicant either contracted with one or more clinical investigators to conduct the studies or submitted studies conducted by others not under contract to the applicant.
Document History
April 1, 2023
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
Purpose.
(a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing...
April 1, 2022
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is...
21 CFR PART 54
April 1, 2021
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is...
April 1, 2020
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
Purpose.
(a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing...
April 1, 2019
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is...
April 1, 2018
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
Purpose.
(a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing...
April 1, 2017
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
Purpose.
(a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing...
April 1, 2016
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is...
April 1, 2015
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
Purpose.
(a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing...
April 1, 2014
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is...