Source: https://www.law.cornell.edu/cfr/text/21/54.1
Timestamp: 2015-07-03 22:57:24
Document Index: 311047220

Matched Legal Cases: ['art 54', '§ 54', 'art 54', '§ 321', '§ 331', '§ 351', '§ 352', '§ 353', '§ 355', '§ 360', '§ 360', '§ 360', '§ 360', '§ 221', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 371', '§ 372', '§ 373', '§ 374', '§ 375', '§ 376', '§ 379']

21 CFR 54.1 - Purpose. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter A › Part 54 › Section 54.1 21 CFR 54.1 - Purpose.
§ 54.1
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 applications and reclassification petitions for medical devices.
The agency reviews data generated in these clinical studies to determine whether the applications are approvable under the statutory requirements. FDA may consider clinical studies inadequate and the data inadequate if, among other things, appropriate steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize bias. One potential source of bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study because of the way payment is arranged (e.g., a royalty) or because the investigator has a proprietary interest in the product (e.g., a patent) or because the investigator has an equity interest in the sponsor of the covered study. This section and conforming regulations require an applicant whose submission relies in part on clinical data to disclose certain financial arrangements between sponsor(s) of the covered studies and the clinical investigators and certain interests of the clinical investigators in the product under study or in the sponsor of the covered studies. FDA will use this information, in conjunction with information about the design and purpose of the study, as well as information obtained through on-site inspections, in the agency's assessment of the reliability of the data.
Title 21 published on 2014-04-01.No entries appear in the Federal Register after this date, for 21 CFR Part 54.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeU.S. Code: Title 21 - FOOD AND DRUGS§ 321 - Definitions; generally§ 331 - Prohibited acts§ 351 - Adulterated drugs and devices§ 352 - Misbranded drugs and devices§ 353 - Exemptions and consideration for certain drugs, devices, and biological products§ 355 - New drugs§ 360 - Registration of producers of drugs or devices§ 360c - Classification of devices intended for human use§ 360d - Performance standards§ 360e - Premarket approval21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,§ 360f - Banned devices§ 360g - Judicial review§ 360h - Notification and other remedies§ 360i - Records and reports on devices§ 360j - General provisions respecting control of devices intended for human use§ 371 - Regulations and hearings§ 372 - Examinations and investigations§ 373 - Records§ 374 - Inspection§ 375 - Publicity§ 376 - Examination of sea food on request of packer; marking food with results; fees; penalties§ 379 - Confidential information