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Virtual Training Course

Apr 27, 2020 2:15 PM - Apr 30, 2020 10:30 PM

Regulatory Affairs for Combination Products

Attend this virtual training course to learn about FDA's approach to regulation of combination products, the processes to streamline development of single entity, and aligning requirements between drugs and devices.

Back to Agenda

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

  • 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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