Transforming Regulatory science 2012: Making a difference

Clinical Pharmacology and Therapeutics

Volumn 91, Issue 3, 2012, Pages 375-377

  Goodman, J L ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CRIZOTINIB; VEMURAFENIB;

DRUG EFFICACY; DRUG LEGISLATION; DRUG QUALITY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; HUMAN; LUNG NON SMALL CELL CANCER; MELANOMA; PRIORITY JOURNAL; PUBLIC HEALTH; REVIEW;

COOPERATIVE BEHAVIOR; DRUG AND NARCOTIC CONTROL; HEALTH SERVICES NEEDS AND DEMAND; HUMANS; PHARMACEUTICAL PREPARATIONS; PUBLIC HEALTH; RESEARCH; SCIENCE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84857216811     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.329     Document Type: Review

References (10)

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2. US Food and Drug Administration, Center for Drug Evaluation and Research. Vemurafenib 〈http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm268241.htm〉 (2011).
3. US Food and Drug Administration, Center for Drug Evaluation and Research. Crizotinib 〈http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm270058.htm〉 (2011).
4. US Food and Drug Administration. Advancing Regulatory Science at FDA: A Strategic Plan 〈http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/ RegulatoryScience/UCM268225.pdf〉 (August 2011).
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6. Rathore, A.S. & Winkle, H. Quality by design for biopharmaceuticals. Nat. Biotechnol. 27, 26-34 (2009).
7. US Food and Drug Administration. Driving Biomedical Innovation: Initiatives to Improve Products for Patients 〈http://www.fda.gov/AboutFDA/ ReportsManualsForms/Reports/ucm274333.htm〉 (October 2011).
8. US Food and Drug Administration. FDA outlines plans for an outside network of scientific experts 〈http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm274351.htm〉 (4 October 2011).
9. US Food and Drug Administration. FDA's sentinel initiative: transforming how we monitor the safety of FDA-regulated products 〈http://www.fda.gov/ Safety/FDAsSentinelInitiative/ucm2007250.htm〉. Accessed 7 November 2011.
10. Foundation for the National Institutes of Health. Observational Medical Outcomes Partnership 〈http://omop.fnih.org/〉. Accessed 7 November 2011.