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Cited by 335Pharmaceutical industry and healthcareEthics in Clinical ResearchHealthcare Regulation

The DOI matches its Crossref record; 11 of the 11 references it cites were found in a registry or an index.

Trial Reporting in ClinicalTrials.gov — The Final Rule

Open access
Zarin, Deborah A., Tse, Tony, Williams, Rebecca J., Carr, Sarah·2016·New England Journal of Medicine
DOI 10.1056/nejmsr1611785PMC PMC5225905
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Abstract

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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Research works printed but not linked: 3

  1. Department of Health and Human Services, 2016, Fed Regist, 81, 64981
  2. National Institutes of Health, 2016, Fed Regist, 81, 64922
  3. Hudson KL, JAMA

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Metadata

Authors
Zarin, D. A., Tse, T., Williams, R. J., & Carr, S.
Affiliations
National Institutes of Health (US)
ORCID
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
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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