美国FDA 指导原则 IND提交的针对严重衰弱或危及生命的疾病的个体化反义寡核苷酸药物产品的临床建议 英文原版.pdfVIP

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美国FDA 指导原则 IND提交的针对严重衰弱或危及生命的疾病的个体化反义寡核苷酸药物产品的临床建议 英文原版.pdf

IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations Guidance for Sponsor-Investigators DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comm

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