GUIDANCE DOCUMENT
Draft
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2024-D-3780
- Docket Number:
- FDA-2024-D-3780
- Issued by:
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Guidance Issuing Office
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Developing Drugs for Optical Imaging.” The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that support development and approval of optical imaging drugs that are used in conjunction with imaging devices and intended as intraoperative aids for the detection of pathology such as tumors or to enhance the conspicuity of normal anatomical structures.
