Many mission-critical therapeutic solutions may be found in combination products. In this presentation the Agency will provide information to assist industry in its development, application submission, and CGMP compliance of these products. Highlights of the recent and evolving regulatory environment that have implications for innovative therapeutic solutions, include: • The Genus Court Decision • The QSR Amendment Proposed Rule • FDA Remote Regulatory Assessments (RRA) and how combination products have been impacted • De Novo and other recent submission approvals Combination product manufacturing case studies will also be presented, reflecting the impacts of evolving expectations.
Consumer Safety Officer, Office of Pharmaceutical Quality,
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