The Draft Guidance emphasizes up front that the requirement that the platform technology has the potential to be incorporated in, or utilized by, more than one drug excludes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The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing ...

Researchers at the Ludwig Center at Harvard have developed a platform technology for imaging that enables integration of the methods of microscopic analysis long employed in pathology laboratories ...

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 ...