WebJan 17, 2024 · The information on this page is current as of Jan 17, 2024. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 312.1 - Scope. § 312.2 - Applicability. § 312.3 - Definitions and interpretations. § 312.6 … (e) Numbering of IND submissions. Each submission relating to an IND is required … (a) Applicability. Except as provided in this section, this part applies to all clinical … (a) An investigational new drug may be used in a clinical investigation if the … (a) The sponsor shall monitor the progress of all investigations involving an … (a) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical … An IND may be submitted for one or more phases of an investigation. The clinical … WebMar 31, 2024 · Forms: Form FDA 1571 (PDF - 221KB ): Investigational New Drug Application (IND) Form FDA 1572 (PDF - 208KB): Statement of Investigator. Form FDA …
eCFR :: 21 CFR Part 312 -- Investigational New Drug …
WebApr 11, 2024 · 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) and of the licensing provisions of the Public Health Service Act (42 U.S.C. 201 et … Web•Extensive understanding of 21 CFR Part 800-1299, 21 CFR Part 820 Quality System Regulation, 21 CFR Part 210, Quality System Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP ... umn service learning
CFR - Code of Federal Regulations Title 21 - Food and …
WebAn electronic version of this guidance is also available via Internet by connecting to the CDER file transfer protocol (FTP) server (CDVS2.CDER.FDA.GOV). GUIDANCE FOR INDUSTRY1 CONTENT AND... WebJan 17, 2024 · The information on this page is current as of Jan 17, 2024. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations … WebAn investigational new drug is defined by the Code of Federal Regulations (CFR) as “a new drug or biological drug that is used in a clinical investigation.” In other words, it is any new drug, vaccine, or other biological product for which FDA approval is being sought. Unlike FDA-approved substances that are commercially available, the ... thorne elementary school archives