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.

Search help
62 results
  1. NLM Digital Collections - Qualification process for drug development tools : guidance for industry and FDA staff 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
    resource.nlm.nih.gov/9918249007706676
    ... gov/drugs/drug-development-tool-ddt-qualification-programs/clinical-outcome-assessments-coa- qualification-submissions and Qualified COAs at https://www.fda. ...
  2. NLM Digital Collections - Human gene therapy for rare diseases 
    Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
    resource.nlm.nih.gov/101767660
    ... fda.gov/drugs/drug- development-tool-qualification-programs/clinical-outcome-assessment-coa-qualification- program. 18. Guidance for Industry: Expedited Programs for ...
  3. NLM Digital Collections - Drug and device manufacturer communications with payors, formulary committees, and similar ... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
    resource.nlm.nih.gov/101734304
    ... tool developers, and Food and Drug Administration staff Qualification of ... clinician-reported outcomes, observer-reported outcomes, and performance ...
  4. NLM Digital Collections - Eosinophilic esophagitis : developing drugs for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
    resource.nlm.nih.gov/9918232103706676
    ... alteration, dyskeratotic epithelial cells, lamina propria fibrosis). 2. Clinical Outcome Assessments Sponsors developing drugs for the treatment of EoE should consider the following when using COA instruments, including PRO and ObsRO instruments: • FDA encourages ...
  5. NLM Digital Collections - Principles for selecting, developing, modifying, and adapting patient-reported outcome ... 
    Publication: Silver Spring, MD : Center for Devices and Radiological Health, January 26, 2022
    resource.nlm.nih.gov/9918351274306676
    ... about-fda/cdrh-patient-science-and-engagement-program/clinical-outcome-assessments- coas-medical-device-decision-making 11 https://www.fda.gov/media/109629/download 12 See FDA’s guidance “Qualification of Medical Device Development Tools,” available at https:// ...
  6. NLM Digital Collections - Hospital literature index (Volume 48) 
    resource.nlm.nih.gov/7807587X35
    ... 1992 Jan-Feb;14(l):24-9 COAD (clinical outcome assessment documentation) charting: using the quality improvement process to ... 1992 Mar-Apr;14(2):30-2 COAD (clinical outcome assessment documentation) charting: using the quality improvement process to ...
  7. NLM Digital Collections - Hospital and health administration index (Volume 53) 
    resource.nlm.nih.gov/9601831X3
    ... 1): 128-38; discussion 126-7 (32 ref.) Outcome assessment for clinical trials: how many adjudicators do we need? Canadian ... Healthc 1996 Sep-Oct; l(5):266-8 Outcome assessment for clinical trials: how many adjudicators do we need? Canadian ...
  8. NLM Digital Collections - Hospital and health administration index (Volume 51) 
    resource.nlm.nih.gov/9601831X1
    ... 7, 90 Shulkin DJ, Brennan PJ. (Office of Clinical Outcome Assessment and Quality Management, University of Pennsylvania Medical Center, ...
  9. NLM Digital Collections - Hospital and health administration index (Volume 54) 
    resource.nlm.nih.gov/9601831X4
    ... 1998 Aug; 19(1):48—65 STANDARDS Best clinical practice': assessment of processes of care and of outcomes in the US Military Health Services System. Krakauer ...
  10. NLM Digital Collections - Hospital literature index (Volume 44) 
    resource.nlm.nih.gov/7807587X31
    ... 7 Rettig PF see Chaiken BP Rettig R: Assessment of medical technology cited to outcome analysis. Healthspan 1988 Jan;5(l):9-14 Reuben DB, Smith SR: Community health projects as part of a core clinical clerkship: teaching research skills in a community setting. ...
first · previous · 1 · 2 · 3 · 4 · 5 · 6 · next · last