Document:USA 21 CFR Part 54 09-Apr-2025
From GxPlex
| Document information | |
|---|---|
| Reference | USA 21 CFR Part 54 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 21 CFR Part 54 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 21 âFood and Drugs
Chapter I âFood and Drug Administration, Department of Health and Human Services Subchapter AâGeneral Part 54 Financial Disclosure by Clinical Investigators https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-001 | G | § 54.1 | EN | § 54.1 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 ... |
| Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 list of investigators | G | § 54.4
list of investigators || EN || § 54.4 Certification and disclosure requirements. For purposes of this part, an applicant must submit a list of all clinical investigators who conducted covered clinical studies to determine whether ... | ||
| Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 disclosure | G | § 54.4
disclosure || EN || § 54.4 Certification and disclosure requirements. [âŚ] Clinical investigators subject to investigational new drug or investigational device exemption regulations must provide the sponsor of the study ... | ||
| Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-002 | G | § 54.1 | EN | § 54.1 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 ... |
| Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.6 | G | § 54.6 | EN | § 54.6 Recordkeeping and record retention. (a) Financial records of clinical investigators to be retained. An applicant who has submitted a marketing application containing covered clinical studies ... |
