Web§ 312.50 General responsibilities of sponsors. Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and …

IND Application Template: - University of Pittsburgh

Web21 rows · IND Section eCTD Module 1. FDA Form 1571 1.1.1 Application Form 2. Table of Contents Not ... WebJan 17, 2024 · Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, … gallaghers credit insurance

Investigation Plan Template - i-Sight

WebA cross-reference letter or package insert may be submitted in lieu of required information for sections: 3 (Introductory Statement and General Investigational Plan), 4 (Investigator’s Brochure), 6 (Chemistry, Manufacturing, and Control Data), 7 (Pharmacology and Toxicology Data), and 8 (Previous Human Experience). Web9 Additional Meeting Information Other meetings which may take place during the life-cycle of an IND include: End of Phase 1 meetings (21 CFR 312.82) End of Phase 2/Pre-phase 3 meetings (21 CFR 312.47) Pre-BLA (Biologics Licensing Application) meetings (21 CFR 312.47) For more information, please see “Guidance for Industry: Formal Meetings with … WebApr 13, 2024 · 1 GENERAL INVESTIGATIONAL PLAN FOR INITIAL IND. XXXXX (XXX) is developing the investigational product XXXXX (XXXX) for the treatment of Parkinson’s Disease (PD) via the 505(b)(2) pathway. XXXXX has been FDA-approved since 1981, under the trade name XXXXX (NDA XXXXXX). XXXXX is a regulating agent and is indicated … gallaghers cork menu