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DIA Global Center

Oct 17, 2018 8:15 AM - Oct 18, 2018 4:15 PM

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

Regulatory Affairs for Combination Products

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Session 10: Post-Approval Changes (CMC, Manufacturing, and Labeling)

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

Device supplements
Drug supplements
Application to Combination Products
Device and Drug Changes Made to Products Approved via PMA
Device and Drug Changes Made to Products Approved via NDA

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