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Title
Regulatory Rapporteur November 2019
Summary
FOCUS: North America - A look at recent developments in the regulatory landscape across the region PLUS • Orphan drugs: The practicalities of using the EMA’s IRIS platform • Medical devices: New device standards from the US FDA consensus list • Letters: Nonclinical requirements for biotech-derived drugs
DocumentAccess
Regulatory Rapporteur November 2019MEMBERS
The European Medicines Agency’s online IRIS platform: one year onMEMBERS
Biopharmaceutical regulatory intelligence programmes: current status and trendsMEMBERS
Medical device standards updateMEMBERS
Interview: Outlook on healthcare regulatory affairs in the USMEMBERS
A regulatory landscape shift for in silico clinical trialsMEMBERS
How regulatory practice in North America reflects global policy PUBLIC
Moving from unstructured to structured data – US nonclinical data standards PUBLIC
Managing an FDA new drug application from outside the US: a case study PUBLIC
Letters to the editor PUBLIC