United States Government Publishing Office
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United States
National Archives and Records Administration
Office of the Federal Register
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2017-01-09
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Financial Disclosure by Clinical Investigators; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part IV
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The Food and Drug Administration (FDA) is proposing to require that the sponsor of any drug, biological product, or device submit certain information concerning the compensation to, and financial interests of, any clinical investigator conducting clinical studies to determine whether that product meets the marketing requirements specified by the agency. This requirement will apply to most clinical studies involving human subjects, as well as any study to establish bioavailability or bioequivalence. The agency is proposing to require that sponsors certify to the absence of certain financial interests of clinical investigators or disclose those financial interests when clinical studies are submitted to FDA in support of product marketing. If the agency adopts this proposal, and the sponsor does not include one of the required submissions with the application for marketing a covered product that contains clinical data, the agency will refuse to file the application. FDA will propose to extend these requirements to submissions for marketing approval related to human foods, animal foods, and animal drugs in a notice to be published in a subsequent issue of the Federal Register. FDA is seeking public comment on these proposed requirements.
59 FR 0
https://www.govinfo.gov/app/details/FR-1994-09-22/94-23414
94-23414
fr22se94-27
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Federal Register: September 22, 1994
https://www.govinfo.gov/app/details/FR-1994-09-22/94-23414
https://www.govinfo.gov/content/pkg/FR-1994-09-22/html/94-23414.htm
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59 FR 0
Code of Federal Regulations
Title 21 Part
21 CFR Part
Code of Federal Regulations
Title 21 Part 54
21 CFR Part 54
Financial Disclosure by Clinical Investigators; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES; Federal Register Vol. 59, Issue
UNKNOWN
94-23414
IV
1994-12-21
Federal Register: September 22, 1994
4160-01-P
94-23414
Proposed rule.
The Food and Drug Administration (FDA) is proposing to require that the sponsor of any drug, biological product, or device submit certain information concerning the compensation to, and financial interests of, any clinical investigator conducting clinical studies to determine whether that product meets the marketing requirements specified by the agency. This requirement will apply to most clinical studies involving human subjects, as well as any study to establish bioavailability or bioequivalence. The agency is proposing to require that sponsors certify to the absence of certain financial interests of clinical investigators or disclose those financial interests when clinical studies are submitted to FDA in support of product marketing. If the agency adopts this proposal, and the sponsor does not include one of the required submissions with the application for marketing a covered product that contains clinical data, the agency will refuse to file the application. FDA will propose to extend these requirements to submissions for marketing approval related to human foods, animal foods, and animal drugs in a notice to be published in a subsequent issue of the Federal Register. FDA is seeking public comment on these proposed requirements.
Written comments on or before December 21, 1994. The agency is proposing that any final rule that may issue based on this proposed rule become effective 6 months after the date of its publication.
John S. Ensign, Office of Health Affairs (HFY-22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852, 301-443-1382.
Federal Register
Vol. 59, no. 183
Office of the Federal Register, National Archives and Records Administration
1994-09-22
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