CFDA Issues ‘User Friendly’ Device Study Guidance
This article was originally published in PharmAsia News
The China Food and Drug Administration has for the first time issued guidance that explains how medical device makers should conduct clinical evaluations of the products they seek to register in China, and in which cases they may obtain a clinical study waiver.
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The sponsors of seven new drugs are set to find out this week whether the European Medicines Agency’s human medicines committee, the CHMP, will recommend pan-EU approval for their products. CHMP action is also expected regarding two potential combination therapies for COVID-19.
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