🩺FDA Draft Guidance on Developing Drugs for Optical Imaging
Developing Drugs for Optical Imaging; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Developing Drugs for Optical Imaging."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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance on developing drugs for optical imaging presents important regulatory requirements for businesses involved in drug development and manufacturing. It highlights clinical trial design considerations crucial for compliance and market approval, impacting operational and financial strategies.