Simplifying Global Compliance
Are you hoping for a one cycle approval of your ANDA? This report explains how to meet the challenges and avoid the pitfalls in pursuing first-cycle ANDA approval.
Your smart phone is not a medical device. Your tablet is not a medical device. Your fitbit is not a medical device. They’re not subject to FDA regulation.
From January 2010 through June 2015, the FDA issued 89 warning letters to clinical investigators, sponsors and IRBs for good clinical practices (GCP) violations.
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