Business · 28/12/2011

FDA Releases Draft Guidance on CDRH Appeals Processes

The Food and Drug Administration (FDA) has released a draft guidance document outlining the appeals processes for the Center for Devices and Radiological Health (CDRH), allowing outside stakeholders to request additional review of decisions and actions by CDRH employees. The document provides general information and guidance on submitting related requests to CDRH and FDA.