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GUIDANCE DOCUMENT

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex May 2018

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2018-D-1609
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures.

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All written comments should be identified with this document's docket number: FDA-2018-D-1609.