Life Science Compliance Update

November

2017

Increasing the Tension – Expanding Patient Access to Investigational Medical Products

Written by , Posted in Uncategorized

Maureen Lloyd a Health Industries, Risk and Regulatory Director and Dixil Francis a Health Industries, Risk and Regulatory Manager at PWC

Expanding patient access to therapies currently being tested but not yet marketed is both increasingly challenging and important. However, despite the many challenges, changing regulations and industry association guidelines have increased pressure on manufacturers to develop or expand their access to medicines programs. Therefore, it is clear that improving appropriate patient access to investigational medical products remains a prominent objective for the life science industry. This article explores the changing environment surrounding expanded patient access and the practical implications facing life science companies trying to balance competing concerns.


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