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GUIDANCE DOCUMENT

PET Drug Products - Current Good Manufacturing Practice (CGMP) December 2009

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1998-D-0025
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to help positron emission tomography (PET) drug producers better understand FDA’s thinking concerning compliance with the current good manufacturing practice (CGMP) regulations. The guidance addresses resources, procedures, and documentation for all PET drug production facilities, academic and commercial. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements.

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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-1998-D-0025.

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