WebJan 17, 2024 · A sponsor of a clinical study of a drug marketed or approved in the United States that is conducted under an IND is required to submit IND safety reports for suspected adverse reactions that... WebMar 31, 2024 · Forms: Form FDA 1571 (PDF - 221KB ): Investigational New Drug Application (IND) Form FDA 1572 (PDF - 208KB): Statement of Investigator. Form FDA …
Federal Register/ Vol. 88, No. 69 / Tuesday, April 11, 2024 / …
WebJan 17, 2024 · CFR - Code of Federal Regulations Title 21 FDA Home Medical Devices Databases The information on this page is current as of Jan 17, 2024. For the most up-to-date version of CFR Title 21, go... WebJan 17, 2024 · CFR - Code of Federal Regulations Title 21 FDA Home Medical Devices Databases The information on this page is current as of Jan 17, 2024. For the most up-to-date version of CFR Title 21, go... csld fuel tank tests
Investigational New Drug Applications (INDs) for CBER …
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 seq.) that govern investigational new drugs and investigational new drug applications (INDs). Implementing regulations are found in part 312 (21 CFR part 312) and provide for the Web( c) A description of the general investigational plan for the coming year to replace that submitted 1 year earlier. The general investigational plan shall contain the information required under § 312.23 (a) (3) (iv). ( d) If the investigator brochure has been revised, a description of the revision and a copy of the new brochure. WebWhenever a sponsor intends to conduct a study that is not covered by a protocol already contained in the IND, the sponsor shall submit to FDA a protocol amendment containing the protocol for the study. Such study may begin provided two conditions are met: ( 1) The sponsor has submitted the protocol to FDA for its review; and csl dewey ave