Civil money penalties relating to the ClinicalTrials.gov data bank: guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body. United States. Food and Drug Administration. issuing body. United States. Food and Drug Administration. Office of Good Clinical Practice, issuing body. United States. Food and Drug Administration. Office of Regulatory Affairs, issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : United States Food and Drug Administration, Office of Good Clinical Practice. August 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Clinical Trials as Topic Databases as Topic Data Management -- legislation & jurisprudence United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- This guidance document is intended to describe the current thinking of FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) (hereafter, "Center" or collectively, "the Centers"), regarding civil money penalties under section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). That section authorizes FDA to assess civil money penalties against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products (hereafter, "submitters") who violate applicable FD&C Act prohibitions relating to requirements under section 402(j) of the Public Health Service Act (PHS Act), including its implementing regulations in 42 CFR part 11, to submit clinical trial registration and/or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (9 pages)).
- NLM Unique ID:
- 9918227360006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918227360006676