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# CBER Staff Guide on IND Processing, Review
- URL: https://www.fdaweb.com/cber-staff-guide-on-ind-processing-review/
- Published: 2024-07-10T12:00:00.000Z
- Updated: 2026-09-14T14:35:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157322

CBER has published a standard operating policy and procedure (SOPP), *Administrative Processing and Review Management Procedures for Investigational New Drug Applications*, as a guide to Center staff. The [SOPP](https://www.fda.gov/media/156718/download?attachment&ref=fdaweb.com) applies to INDs received by CBER, including those for expanded access, except for individual emergency use requests. It does not address the specific content of scientific reviews.

CBER says this SOPP is a part of the Center’s Managed Review Process that intends to provide a quality and efficient process for all applications and submissions related to medical products it regulates.