FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision
The Draft Guidance emphasizes up front that the requirement that the platform technology has the potential to be incorporated in, or utilized by, more than one drug excludes some technologies that the ...
The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing ...
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