FDA Warning Letters Related to Pharmacovigilance Operations

DR. CHITRA LELE | April 22, 2016

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Regulatory inspections are an everyday reality now, given the heightened level of scrutiny that the industry is facing from all the regulators. We at Sciformix recently conducted a DIA webinar on the topic of FDA warning letters in the context of Pharmacovigilance (PV) operations. We focused specifically on the post-marketing safety monitoring related findings in the warning letters issued by the FDA. I am summarizing a few key points here from the discussion in the webinar.

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