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GUIDANCE DOCUMENT

PET Drug Applications - Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011 September 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2000-D-1542
Issued by:
Guidance Issuing Office
Center 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.

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All written comments should be identified with this document's docket number: FDA-2000-D-1542.

 
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