FDA Patient-Focused Drug Development Guidances-Reference-Cited by-同舟云学术

FDA Patient-Focused Drug Development Guidances

Published:2024-01-09 Issue:1 Volume:102 Page:
ISSN:0028-3878
Container-title:Neurology
language:en
Short-container-title:Neurology

Author:

Berg Anne T.¹^ORCID,Ludwig Natasha N.¹^ORCID,Wojnaroski Mary¹^ORCID,Chapman Chere A.T.¹^ORCID,Hommer Rebecca¹^ORCID,Conecker Gabrielle¹^ORCID,Hecker JayEtta Z.¹^ORCID,Downs Jenny¹^ORCID

Affiliation:

1. From the Department of Neurology (A.T.B.), Northwestern-Feinberg School of Medicine, Chicago, IL; Decoding Developmental Epilepsies (A.T.B., G.C., J.Z.H.), Washington, DC; Department of Neuropsychology (N.N.L.), Kennedy Krieger Institute; Department of Psychiatry and Behavioral Sciences (N.N.L.), The Johns Hopkins School of Medicine, Baltimore, MD; Department of Psychology (M.W.), Nationwide Children's Hospital; Department of Pediatrics (M.W.), The Ohio State University, Columbus; Ardea Outcomes (C...

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Neurology (clinical)

Link

https://www.neurology.org/doi/pdfdirect/10.1212/WNL.0000000000207958

Reference42 articles.

1. United States Government. 21st Century Cures Act. H.R. 34. 114th Congress; 2016. Accessed March, 2023. gpo.gov/fdsys/pkg/BILLS-114hr34enr/pdf/BILLS-114hr34enr.pdf.

2. Federal Drug Administration. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. US Department of Health and Human Services; 2020. Accessed March, 2023. fda.gov/media/139088/download.

3. Food and Drug Administration. Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-forPurpose Clinical Outcome Assessments Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders (Draft Guidance). US Department of Health and Human Services; 2022. Accessed March, 2023. fda.gov/media/159500/download.

4. Food and Drug Administration. Patient-Focused Drug Development: Methods to Identify What Is Important to Patients. Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. US Department of Health and Human Services; 2022. Accessed March 17, 2023. fda.gov/media/131230/download.

5. Food and Drug Administration. Precision Medicine [online]. Accessed March 17, 2023. fda.gov/medical-devices/in-vitro-diagnostics/precision-medicine.