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Points To Consider For The Submission of Chemistry, Manufacturing, and Controls (CMC) Information in Oligonucleotide-Based Therapeutic Drug Applications* Rao V.B. Kambhampati, Ph.D. Senior Regulatory Review Scientist (Chemist) Food and Drug Administration Center for Drug Evaluation and Research Office of New Drug Quality Assessment Silver Spring, MD 20993 *The recommendations in this presentation merely represent...
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