federal_register: 2021-26454

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2021-26454 Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations." This draft guidance provides FDA's recommendations on the chemistry, manufacturing, and controls (CMC) information needed to support an investigational new drug application (IND) submitted by a sponsor-investigator developing an individualized antisense oligonucleotide (ASO) drug product for a severely debilitating or life-threatening (SDLT) disease caused by a unique genetic variant affecting a small number of individuals (typically one or two). 2021-12-08 2021 12 https://www.federalregister.gov/documents/2021/12/08/2021-26454/investigational-new-drug-application-submissions-for-individualized-antisense-oligonucleotide-drug https://www.govinfo.gov/content/pkg/FR-2021-12-08/pdf/2021-26454.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening...

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