Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable

Author:

Dreyer Nancy A.

Publisher

Springer Science and Business Media LLC

Subject

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

Reference32 articles.

1. Gottlieb S. Speech to Regulatory Affairs Professionals Society 2017 Regulatory Conference; September 11, 2017; Washington DC.

2. Gottlieb S. Written remarks provided at the conference “Examining the impact of real-world evidence on medical product development.” National Academy of Sciences, Washington DC; September 20, 2017.

3. US Public Law No: 114-255.

4. Anderson ML, Griffin J, Goldkind SE, et al. The Food and Drug Administration and pragmatic clinical trials of marketed products. Clin Trials 2015;12:511–519.

5. Cerrata F, Eichler HG, Rasi G. Drug policy for an aging population: The European Medicines Agency’s Geriatric Medicines Strategy. N Engl J Med. 2012:36;1972–1974.

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