#1
Deadline Extended for DMF Type III...by Makro Care
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401USFDA Extended the Compliance date for the submission of type III Drug Master Files In eCTD for until May 5, 2020. The DMF Guidance recommends the DMF holders to update...
#2
Performance Evaluation Report (PER...by Swapna Makro101
101From IVDR perspective, clinical evidence should support the intended purpose of a device as stated by the manufacturer and that is based on performance evaluation. This...