The Pre-IND Meeting. What CBER Reviewers Actually Want to See.
Year: 2026
Type: article
Abstract: Describes the Pre-IND meeting with CBER as a Type B meeting and what reviewers look for in the briefing package. Explains why a written response can serve as a citable agency position and how sponsors should present pathway and CMC information.
Author: Hillman, Andrew Jonathan
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7221707342
FWCI:
Cites:
Cited by:
Related to: