The PCAST report on pharmaceutical innovation: Implications for the FDA

Clinical Pharmacology and Therapeutics

Volumn 94, Issue 3, 2013, Pages 297-300

  Woodcock, J ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

COST BENEFIT ANALYSIS; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; MEDICAL RESEARCH; NATIONAL HEALTH ORGANIZATION; PRIORITY JOURNAL; REVIEW; DRUG INDUSTRY; GOVERNMENT REGULATION; INVENTION; PUBLIC-PRIVATE PARTNERSHIP; UNITED STATES;

DRUG INDUSTRY; GOVERNMENT REGULATION; INVENTIONS; PUBLIC-PRIVATE SECTOR PARTNERSHIPS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84883143935     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2013.88     Document Type: Review

References (9)

1. Executive Office of the President, President's Council of Advisors on Science and Technology. Propelling innovation in drug discovery, development and evaluation (25 September 2012).
2. Collins, F.S. Reengineering translational science: the time is right. Sci. Transl. Med. 6, 90cm17 (2011).
3. US Department of Health and Human Services, Food and Drug Administration. Innovation or stagnation: challenge and opportunity on the critical path to new medical products (March 2004). .
4. National Institutes of Health. Joint NIH-Industry Target Validation Workshop. Executive summary (3-4 November 2011)..
5. US Food and Drug Administration. Biomarker qualification program (5 March 2013). Accessed 4 April 2013.
6. I-SPY 2. Clinical trial for women with newly diagnosed locally advanced breast cancer ..
7. US Food and Drug Administration Safety and Innovation Act. Pub. L. No. 112-44, 126 Stat. 993 (9 July 2012).
8. US Food and Drug Administration. Creating an alternative approval pathway for certain drugs intended to address unmet medical need. Public hearing. (4 February 2013).
9. US Food and Drug Administration. FDA's Sentinel Initiative (20 May 2013). Accessed 4 April 2013.