The critical path initiative: Leveraging collaborations to enhance regulatory science

Clinical Pharmacology and Therapeutics

Volumn 91, Issue 3, 2012, Pages 380-383

  Barratt, R A ^a   Bowens, S L ^a   McCune, S K ^a   Johannessen, J N ^a   Buckman, S Y ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PATHWAY; DRUG DEVELOPMENT; GOVERNMENT; INFORMATION TECHNOLOGY; MEDICAL SOCIETY; PRIORITY JOURNAL; PUBLIC-PRIVATE PARTNERSHIP;

ANIMALS; COOPERATIVE BEHAVIOR; CRITICAL PATHWAYS; DRUG AND NARCOTIC CONTROL; DRUG DISCOVERY; HUMANS; INDUSTRY; SCIENCE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84857197691     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.318     Document Type: Article

References (12)

1. US Food and Drug Administration. Challenges and opportunities report. Innovation or stagnation: challenge and opportunity on the Critical Path to new medical products 〈http://www.fda.gov/ScienceResearch/SpecialTopics/ CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262. htm〉 (March 2004).
2. Woosley, R.L., Myers, R.T. & Goodsaid, F. The Critical Path Institute's approach to precompetitive sharing and advancing regulatory science. Clin. Pharmacol. Ther. 87, 530-533 (2010).
3. Goodsaid, F.M. et al. Novel biomarkers of acute kidney toxicity. Clin. Pharmacol. Ther. 86, 490-496 (2009).
4. Dieterle, F. et al. Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nat. Biotechnol. 28, 455-462 (2010).
5. Huang, S.-M., Zhang, L. & Giacomini, K.M. The International Transporter Consortium (ITC): a collaborative group of scientists from academia, industry and FDA. Clin. Pharmacol. Ther. 87, 32-36 (2010).
6. Huang, S.-M. & Woodcock, J. Transporters in drug development: advancing on the Critical Path. Nat. Rev. Drug Discov. 9, 175-176 (2010).
7. The International Transporter Consortium; Giacomini, K.M. et al. Membrane transporters in drug development. Nat. Rev. Drug Discov. 9, 215-236 (2010).
8. Throckmorton, D.C. How a US regulator can encourage new science. Clin. Pharmacol. Ther. 86, 471-472 (2009).
9. US Food and Drug Administration. Guidance for industry: qualification process for drug development tools 〈http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf%20last%20 accessed%20August%2029,2011〉 (October 2010).
10. US Food and Drug Administration. Collaborative initiative to fast-track innovations to the public 〈http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/2010/ucm201706.htm〉 (24 February 2010).
11. 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).
12. US Food and Drug Administration. Center for Drug Evaluation and Research. The CDER Science Prioritization and Review Committee. Identifying CDER's Science and Research Needs Report 〈http://www.fda.gov/downloads/Drugs/ ScienceResearch/UCM264594.pdf〉 (July 2011).