Fillable oligonucleotide based therapeutic drug applications form
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 the...
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