Fda Acceptance Of Foreign Clinical Trial Data Feb 2009
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Webinar_Feb 24, 2009
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Fda Acceptance Of Foreign Clinical Trial Data Feb 2009
- 3. FDA Acceptance of Foreign Clinical Trial Data in INDs and NDA/BLA Mukesh Kumar, PhD, RAC Senior Director, Regulatory Affairs Amarex Clinical Research Germantown, MD 20874, USA Tel: 001-240-750-4893 Email: [email_address]
- 9. Global Clinical Trials Source: Clinicaltrials.gov
- 10. Most of FDA-Registered Investigators Are From the Developed Countries Source: Parexel's Bio/Pharmaceutical R&D Statistical Sourcebook 2006/2007 Total No. of Investigators (~23000) Non-US Investigators 9.6% 3.9% 1.3% 1.5% 1.9%
- 21. Thank You! Questions and Comments Mukesh Kumar, PhD, RAC Senior Director, Regulatory Affairs Amarex Clinical Research Germantown, MD 20874, USA Tel: 001-240-750-4893 Email: [email_address]