- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
Date: August 2011
These sample formats for the chemistry, manufacturing, and controls section have been prepared by the PET Steering Committee in the Center for Drug Evaluation and Research at the Food and Drug Administration. This document represents the Agency’s current thinking on the production of these positron emission tomography (PET) drug products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statues, regulations, or both.
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:
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-2000-D-1542.