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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Download the Draft Guidance Document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Not for implementation.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This guidance is being distributed for comment purposes only.

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex

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.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.