Translating New Science Into the Drug Review Process: The US FDA’s Division of Applied Regulatory Science

Author:

Rouse Rodney,Kruhlak Naomi,Weaver James,Burkhart Keith,Patel Vikram,Strauss David G.

Publisher

Springer Science and Business Media LLC

Subject

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

Reference71 articles.

1. US Food and Drug Administration. Statement of FDA mission. https://www.fda.gov/downloads/aboutfda/reportsmanualsforms/reports/budgetreports/ucm298331.pdf. Accessed May 15, 2017.

2. US Food and Drug Administration. Science & research: advancing regulatory science. https://www.fda.gov/scienceresearch/specialtopics/regulatoryscience/. Accessed May 15, 2017.

3. US Food and Drug Administration. Science & research: strategic plan for regulatory science. https://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm. Accessed May 15, 2017.

4. Identifying CDER’s science and research needs report, July 2011. The CDER Science Prioritization and Review Committee (SPaRC). https://www.fda.gov/downloads/Drugs/ScienceResearch/UCM264594.pdf. Accessed May 15, 2017.

5. Assessing CDER’s Drug Safety-Related Regulatory Science Needs and Identifying Priorities, March 2015. The CDER Safety Research Interest Group (SRIG). https://www.fda.gov/downloads/Drugs/ScienceResearch/UCM438138.pdf. Accessed May 15, 2017.

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