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Trial Reporting in ClinicalTrials.gov — The Final Rule

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Zarin, Deborah A., Tse, Tony, Williams, Rebecca J., Carr, Sarah·2016·New England Journal of Medicine

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B) an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3)). ''(2) TYPES OF FEES.-Of the total revenue amount determined for a fiscal year under paragraph (1)-''(A) one-third shall be derived from fees under subsection (a)(1) (relating to human drug applications and supplements); ''(B) one-third shall be derived from fees under subsection (a)(2) (relating to prescription drug establishments); and ''(C) one-third shall be derived from fees under subsection (a)(3) (relating to prescription drug products). ''(3) MODIFIED WORKLOAD ADJUSTMENT FACTOR FOR FISCAL YEAR 2007.-For purposes of paragraph (1)(B), the Secretary shall determine the modified workload adjustment factor by determining the dollar amount that results from applying the methodology that was in effect under subsection (c)(2) for fiscal year 2007 to the amount $354,893,000, except that, with respect to the portion of such determination that is based on the change in the total number of commercial investigational new drug applications, the Secretary shall count the number of such applications that were active during the most recent 12month period for which data on such submissions is available.

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Department of Health and Human Services, 2016, Fed Regist, 81, 64981
National Institutes of Health, 2016, Fed Regist, 81, 64922
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Authors: Zarin, D. A., Tse, T., Williams, R. J., & Carr, S.
Affiliations: National Institutes of Health (US)
ORCID: Zarin, Deborah A.
Tse, Tony
Williams, Rebecca J.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2016-11-17
Volume: 375
Issue: 20
Pages: 1998-2004
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmsr1611785
PMC: PMC5225905
OpenAlex: W2520965749
Cited by: 332
References: 11
Citations by year: 2026: 37 · 2025: 21 · 2024: 20 · 2023: 21 · 2022: 20 · 2021: 34 · 2020: 43 · 2019: 34 · 2018: 46 · 2017: 51 · 2016: 4
FWCI: 56.25
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: public-domain
Locations: New England Journal of Medicine (publishedVersion, public-domain)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Institutes of Health (Z99 LM999999)
Topics: Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Regulation
Keywords: ClinicalTrials.gov, clinical trial registration, final rule, clinical trial reporting, regulatory fees, Investigational New Drug application
MeSH terms: Clinical Trials as Topic, Registries, United States, United States Dept. of Health and Human Services, United States Food and Drug Administration, Databases, Factual, Government Regulation, Mandatory Programs

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