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Regulators Seek Solutions To Manufacturing Woes

Sprawling Global Supply Chains Leave Room For Error

Executive Summary

Over the past few years, frustrating instances of shortages and recalls – particularly generics – have been blamed on inferior quality control at countless suppliers of active pharmaceutical ingredients and finished products, especially those based in India and China.

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Surrogate Endpoints: Benefits, Issues And The Future

On a mild day in April 2016, a Marriott Hotel conference room in Hyattsville, Md., was the scene of one of the most politically charged panel meetings the US Food and Drug Administration held in years. A throng of parents and young boys in wheelchairs hoped to convince a committee to endorse the use of a controversial drug for Duchenne muscular dystrophy, a rare and fatal muscle-wasting disease.

Surrogate Endpoints: Benefits, Issues And The Future

On a mild day in April 2016, a Marriott Hotel conference room in Hyattsville, Md., was the scene of one of the most politically charged panel meetings the US Food and Drug Administration held in years. A throng of parents and young boys in wheelchairs hoped to convince a committee to endorse the use of a controversial drug for Duchenne muscular dystrophy, a rare and fatal muscle-wasting disease.

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