Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical Review-Reference-Cited by-同舟云学术

Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical Review

Published:2020-06-08 Issue:6 Volume:54 Page:1436-1443
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Seifu Yodit,Gamalo-Siebers Margaret,Barthel Friederike M.-S.,Lin Junjing,Qiu Junshan,Cooner Freda,Ruan Shiling,Walley Rosalind

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

https://link.springer.com/content/pdf/10.1007/s43441-020-00170-y.pdf

Reference44 articles.

1. Federal Food, Drug, and Cosmetic Act § 505(d), 21 USC 355(d); 1962.

2. 21st Century Cures-patients. Washington, DC: House, Energy and Commerce Committee. Available at: https://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/analysis/21stCenturyCures/20140516PatientsWhitePaper.pdf. Subscription Required. Accessed 9 Dec 2019.

3. US Food and Drug Administration Center for Drug Evaluation and Research (FDA CDER). Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. Center for Drug Evaluation and Research, Rockville; 1998. https://www.fda.gov/media/71655/download.

4. Food and Drug Administration Modernization Act of 1997 §115, 21 USC 355; 2014.

5. Silverman B. A Baker’s dozen of US FDA efficacy approvals using real world evidence. pink sheet. Published August 07, 2018. Available at: https://pink.pharmaintelligence.informa.com/PS123648/A-Bakers-Dozen-Of-US-FDA-Efficacy-Approvals-Using-Real-World-Evidence. Subscription required. Accessed 9 Dec 2019.

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