Bio News
The National Institute of Food and Drug Safety Evaluation revised its guidance for applicants to incorporate patient experience data into GIFT, an expedited review program for treatments for rare and serious diseases. A patient experience data checklist was added to the GIFT designation application, allowing companies to indicate the type of data and whether it is being submitted. The Ministry of Food and Drug Safety plans to support the rapid approval of treatments that address patients’ needs by incorporating their experiences and perspectives into the review process.
BIOBOOK TEAM
biobookmedia@biobook.co.krParagon Spin-Off Velaris Goes Public Through Reverse Merger With Alaunos
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