Publications

The Pre-IND Meeting. What CBER Reviewers Actually Want to See.

Author: Andrew Jonathan Hillman (ORCID 0009-0001-5396-321X)
Published: , Zenodo. Also published in The Hillman Letter.
DOI: 10.5281/zenodo.23352268 (all versions); this version 10.5281/zenodo.23352269
License: CC BY 4.0

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.

This essay describes FDA regulatory process for educational purposes. It is not legal or regulatory advice.

Read the PDF on ZenodoPermanent DOI recordRead on The Hillman LetterOpenAlex record

Indexed in OpenAlex under author A5139488776.

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