CDEReCATS

WHAT: New electronic system to request a Certificate of Pharmaceutical Product (CPP) online as an alternative to a paper submission

WHO: CDER

WHY:  Possible reduction in certificate processing time, a guided step-by-step application process, real-time validation of data, and e-mail notifications of status updates

HOW: Electronic submission procedures guide

LINK


Emergency use

 

WHAT: Listing of  current and terminated Emergency Use Authorizations that make available diagnostic and therapeutic medical devices

WHO : CDRH

WHY: To diagnose and respond to public health emergencies

LINK


 

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