USFDA inspections go beyond factories and into corporate offices of drug companies
Updated : July 03, 2019 12:06 PM IST
For the safer and more effective use of medicines, the US drug regulator expects companies to monitor the effects of drugs after they have been approved for use.
The USFDA will conduct inspections using a risk-based approach based on the firm’s past compliance history, identified deficiencies, recently approved drugs, and specific inputs from USFDA offices.
The audit is so extensive, that USFDA inspectors aren't just focused on pharmacovigilance department, but are also poring through company emails and social media accounts of corporate communication, sales, marketing, legal and even the administrative departments to search for potential adverse event information reporting.
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