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Zarnestra NDA 21824

Zarnestra NDA 21824

Zarnestra NDA 21824. Qin Ryan MD, PhD DODP/CDER/FDA. Outline. Regulatory Background Clinical Overview and Proposed Indication CTEP-20 Design CTEP-20 Efficacy CTEP-20 Safety Summary. Regulatory Background. Regulatory Background.

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751 views • 55 slides

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242 views • 11 slides
Accessibility at CTEP Member Sites

Accessibility at CTEP Member Sites

Accessibility at CTEP Member Sites. Brock Hefel, Norma Saavedra, Matthew Bruess , Bowen Prince. Background:. Based on a perceived need in the community. Aligns well with CTEP mission. Main goals of the project: Figure out if other sites were having similar struggles.

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113 views • 11 slides
CDMS-CTEP ESYS Integration Overview Steve Friedman, MHSA Chief Operations and Informatics Branch

CDMS-CTEP ESYS Integration Overview Steve Friedman, MHSA Chief Operations and Informatics Branch

CDMS-CTEP ESYS Integration Overview Steve Friedman, MHSA Chief Operations and Informatics Branch. Areas of Integration . CTEP Enterprise System is not critical to this phase of Rave deployment but looking ahead integration needs to occur.

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328 views • 5 slides
LOI and Protocol Review Process OEWG Kickoff Meeting March 23, 2010

LOI and Protocol Review Process OEWG Kickoff Meeting March 23, 2010

LOI and Protocol Review Process OEWG Kickoff Meeting March 23, 2010. James Zwiebel, MD Chief, Investigational Drug Branch CTEP, DCTD, NCI. Timeline pauses if industry negotiations cause delay. LOI. Protocol. LOI. Protocol. Protocol. revision/review and. revision/. review. review.

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206 views • 4 slides

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