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DIA Global Center

Oct 15, 2018 8:15 AM - Oct 16, 2018 3:30 PM

21 Dupont Circle NW, Suite 300, Washington, DC 20036

Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

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Session 2: Types of Submissions Affected by CMC

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., United States

FDA Briefing Package
Investigational New Drug Application (IND)
Investigational Medicinal Product Dossier (IMPD)
New Drug Application (NDA/CTD)
Biologics License Application (BLA)
Common Technical Document (CTD)
Drug Master Files (DMFs)
Abbreviated New Drug Application (ANDA)
Amendments to an IND
Supplements to an Approved NDA/ANDA
IND/NDA Annual Reports

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