Guidance on Tests for DNA Markers, Mutations, Etc.
04/21/2003
Federal Register Notice: FDA is making available a draft guidance for industry entitled Multiplex Tests for Heritable DNA Markers, Mutations, and Expression Patterns. This draft guidance document represents the CDRH’s attempt to continue the dialog with stakeholders on the basic framework for the types of data that should be included in a submission. To download this guidance, click here. To view this notice, click here.
