Richard C. Adams, Deputy Director, Division of Chemistry II, OGD, CDER, FDA, Rockville, MD
What is the task? How do specific components of the CMC requirements contribute to the overall mission? Pharmaceutical Equivalence issues. Modified Release Generics with release mechanisms differing from the RLD. Narrow therapeutic index/Critical care drug products: special cases: should they be treated as such? Issues for problematic drugs.
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