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GUIDANCE DOCUMENT

Bioresearch Monitoring Technical Conformance Guide September 2024

Download the Final Guidance Document
Final
Docket Number:
FDA-2018-D-1216
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This technical conformance guide represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for this technical conformance guide. If you cannot identify the appropriate FDA staff, send an email to cder-edata@fda.hhs.gov or cber.cdisc@fda.hhs.gov.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1216.

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