Regulatory Text
21 C.F.R. § 54.3 — Scope.
§ 54.3 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.
Source: ecfr.gov · govinfo.gov — public domain
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Root-LD Entity Data
◈ Machine-Readable Provenance Record
Root-LD v1.0 · boisestandard.org
Federation ID
BS-CFR21-SEC-3B72B9
Entity Class
REGULATION / FEDERAL-CFR-SECTION
Domain Signature
boisestandard.org
Citation
21 C.F.R. § 54.3
Corpus
CFR — Code of Federal Regulations
Status
✓ ACTIVE
Source
PRIMARY-SOURCE
Source Verified
✓ TRUE
Content Hash
6d44b5102ae1c5ab...
Semantic Edges
Pending — corpus passes queued
The regulatory text of 21 C.F.R. § 54.3 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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Title 21 — Food and Drugs
21 C.F.R. § 1.121 C.F.R. § 1.321 C.F.R. § 1.421 C.F.R. § 1.2021 C.F.R. § 1.2121 C.F.R. § 1.2321 C.F.R. § 1.2421 C.F.R. § 1.7021 C.F.R. § 1.7121 C.F.R. § 1.7221 C.F.R. § 1.7321 C.F.R. § 1.7421 C.F.R. § 1.7521 C.F.R. § 1.7621 C.F.R. § 1.7721 C.F.R. § 1.7821 C.F.R. § 1.7921 C.F.R. § 1.8021 C.F.R. § 1.8121 C.F.R. § 1.8321 C.F.R. § 1.9021 C.F.R. § 1.9121 C.F.R. § 1.9421 C.F.R. § 1.9521 C.F.R. § 1.9621 C.F.R. § 1.9721 C.F.R. § 1.9921 C.F.R. § 1.10121 C.F.R. § 1.22521 C.F.R. § 1.226
21 C.F.R. — public domain
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