Risk Management of the Minimum CMC Regulatory Compliance Continuum

Author:

Geigert John

Publisher

Springer Nature Switzerland

Reference32 articles.

1. ICH website: Members and Observers; www.ich.org/page/members-observers

2. ICH website: Consideration Documents – Gene Therapy Discussion Group; www.ich.org/page/consideration-documents

3. FDA CFR Code of Federal Regulations Title 21 – Part 312.23, IND Content and Format; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.23

4. EMA Guideline on Quality, Non-Clinical and Clinical Requirements for Investigational Advanced Therapy Medicinal Products in Clinical Trials (January 2019); www.ema.europa.eu/en/guideline-quality-non-clinical-clinical-requirements-investigational-advanced-therapy-medicinal

5. FDA Guidance for Industry: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (January 2020); www.fda.gov/regulatory-information/search-fda-guidance-documents/chemistry-manufacturing-and-control-cmc-information-human-gene-therapy-investigational-new-drug

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