FDA Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products

Titel:
FDA Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products
Internet:

https://www.gmp-navigator.com/files/guidemgr/New-Contrast-Imaging-Indication-Considerations-for-Devices-and-Approved-Drug-and-Biological-Products.pdf

Herkunft/Verlag:

FDA

Inhalt:
FDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products (hereinafter more generally referred to as drugs or drug products) that provide image contrast enhancement in determining

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