U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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

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Not for implementation.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This guidance is being distributed for comment purposes only.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.


Submit Comments

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-1609.