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Financial disclosure by clinical investigators (21 CFR 54.1-54.6).

Country/Territory
United States of America
Document type
Regulation
Date
2016 (1999)
Source
FAO, FAOLEX
Original source
Code of Federal Regulations - Title 21 - Food and Drugs.
Subject
Food & nutrition
Keyword
Food quality control/food safety Legal proceedings/administrative proceedings Inspection Authorization/permit
Geographical area
Americas, Arctic, East Pacific, North America, North Atlantic
Abstract

Part 54 of Title 21 of the Federal Code of Regulations defines the financial disclosure by clinical investigators in terms of administrative procedures regarding the clinical studies aimed to determine whether the applications are approvable under the statutory requirement (also for biological products and including the potential increase in the value of the interest if a specific product is approved).

Full text
English
Website
www.gpo.gov

References - Legislation

Implements

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301-399d).

Legislation | United States of America | 1938 (2021)

Keyword: Basic legislation, Food quality control/food safety, Hygiene/sanitary procedures, Packaging/labelling, Food additives, Residues, MRL-maximum residue limit, Standards, Registration, Inspection, Traceability/product tracing, Treated food, HACCP, Fish products, Fraud, Enforcement/compliance, Offences/penalties, Pesticides, Animal health, Animal feed/feedstuffs, Drugs

Source: FAO, FAOLEX