The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing ...
FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision
The Draft Guidance emphasizes up front that the requirement that the platform technology has the potential to be incorporated in, or utilized by, more than one drug excludes some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 ...
If you've kept up-to-date with your Windows news, you'll know that . In its piece, the Redmond giant explained why Windows 11 has TPM 2.0 as part of its system requirements, including data encryption, ...
To speed up drug applications, the FDA has laid out new guidance on how to request a platform designation that can smooth subsequent applications for biotechs working off the same reproducible ...
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