FDA to Conduct Evaluation of Pharmacovigilance Systems

By Daniel R. Matlis

On January 12th, I reported on FDA’s request for Pharmaceutical companies to confirm or repeat all pharmacokinetic studies conducted by MDS Pharma Services from 2000 through 2004.

This week the Agency announced that it will be conducting market research on commercially available pharmacovigilance risk management and product safety computer system products. 

Is this a coincidence?  I think not.

According to FDA’s own data, Corrective And Preventive Action (CAPA) findings represent 50% of the 483s issued to companies during inspections. It would be refreshing to hear that FDA is holding itself to the same standards it holds the industry.

I hope this study represents the first step in the agency’s CAPA process triggered by the MDS findings.

If your company provides pharmacovigilance and product safety systems, or you are already using these systems within your organization, the FDA would like to hear from you.  All requests must be submitted no later than January 31, 2007.

Submit your request to:
Food and Drug Administration
5600 Fishers Lane
Rockville, MD  20857
Attn: Ms. Smale/PKLN RM10B31 HFD-70

or

COTSResearch@fda.hhs.gov

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