Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs - REdI 2020

FDA discusses the types of CMC lifecycle changes, and regulatory implications for those changes with case studies. The real journey of a new drug’s lifecycle begins only after the regulatory approval for that drug entity. Often referred to as postapproval (or post-marketing) is when the applicants start to focus on the economics of the manufacturing and marketing for a given product and indication. Many changes are made to the Chemistry and Manufacturing Controls without changing the fundamental active ingredient.
Presenter:
Ramesh Raghavachari Chief,
Branch I | Division of Post-Marketing Activities | Office of Lifecycle Drug Products (OLDP) Office of Pharmaceutical Quality (OPQ) | CDER
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