| Title | 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Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators; Draft Guidance for Industry; Availability |
| ToC Doc | Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators; Draft Guidance for Industry; Availability |
| Docket Number | 2021-26454 |
| Type | Notice |
| Subject | 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Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators; Draft Guidance for Industry; Availability |
| Publication Date | 2021-12-08 |
| Last Updated Date | 2021-12-07 08:15:17 -0500 |
| Last Public Inspection | 2021-12-07 |
| Filed At | 2021-12-07T08:45:00.000-05:00 |
| 2021-26454_PI.pdf (76139 bytes) | |
| Download | TXT / HTML / JSON |
| Number of Pages | 5 |
| Filing Type | regular |
| Agencies | Food and Drug Administration |
You can find the raw source document below...