Skip to main content
U.S. flag

An official website of the United States government

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

510 results
  1. NLM Digital Collections - Technical specifications for submitting clinical trial data sets for treatment of ... 
    Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022
    ... Ratio Index BDS Basic Data Structure CAC Cardiac Adjudication Committee CDISC Clinical Data Interchange Standards Consortium CK-18 ... Fibrosis FDA Food and Drug Administration HAC Hepatic Adjudication Committee 3 Available at https://www.fda.gov/industry/ ...
  2. NLM Digital Collections - Cytomegalovirus in transplantation : developing drugs to treat or prevent disease 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2020
    ... should be confirmed by an independent, blinded, clinical adjudication committee. FDA recommends that the secondary endpoints in CMV ... invasive 14 CMV disease (as determined by an adjudication committee) was reported with valganciclovir 15 than with oral ...
  3. NLM Digital Collections - E17 general principles for planning and design of multiregional clinical trials 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
    ... is planned, a centralized assessment by a single adjudication committee should be considered. For endpoints based on laboratory or imaging assessments, it is generally recommended that a centralized laboratory or centralized adjudication of imaging be used. If multiple laboratories are ...
  4. NLM Digital Collections - Insulin degludec (Tresiba??, Novo Nordisk A/S) for the treatment of diabetes : effectiveness, ... 
    Publication: [Boston, MA] : Institute for Clinical and Economic Review, March 14, 2016
    ... also influence co- interventions and adherence. The central adjudication committees were masked to treatment assignment, but there could ...
  5. NLM Digital Collections - Chronic hepatitis C virus infection : developing direct-acting antiviral drugs for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
    ... specific to the population. Evaluation by an independent adjudication committee is encouraged to review all serious hepatic events, ...
  6. NLM Digital Collections - Recurrent herpes labialis : developing drugs for treatment and prevention 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
    ... and it would be difficult to have an adjudication committee to add further specificity. The same is expected ...
  7. NLM Digital Collections - Chronic hepatitis B virus infection : developing drugs for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
    ... evaluated during clinical development. Evaluation by an independent adjudication committee is encouraged. For a drug approved for use ...
  8. ... clinically at the participating site and by an adjudication committee unaware of the treatment assignment, on Sl A ...
  9. ... that here the question was not assigned for adjudication to a committee of assorted experts? Surely the problem of the ... that here the question was not assigned for adjudication to a committee of assorted experts? Surely the problem of the ...
  10. ... time I ever heard that this is a committee of adjudication. If it is I don’t want anything ... be here, but not if it is a committee of adjudication. The Chairman. I suppose it is a committee ...
first · previous · 1 · 2 · 3 · 4 · 5 · 6 · 7 · 8 · 9 · 10 · next · last