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When The FDA Is Concerned About Your Ability To Monitor Drugs



A couple of weeks ago, I wrote about a warning letter that was issued to a pharmaceutical company last month. I highlighted one of the FDA’s findings, which had to do with the company’s standard operating procedures (SOPs) having an insufficient amount of detail about their process for collecting adverse events. Today, I want to cover their second finding: “Failure to report each adverse drug experience not reported under 21 CFR 314.80(c)(1)(i) at quarterly intervals as required by 21 CFR 314.80(c)(2)(i).” 

To me, this is a more egregious act than the first, since the act of reporting adverse events to the FDA is one of the most basic, yet important, rules in the drug safety and pharmacovigilance process. While the company responded with a commitment to reporting the late Periodic Adverse Drug Experience Reports (PADERs) and associated Individual Case Safety Reports (ICSRs), they failed to back it up with revisions to their SOPs that would help prevent such instances in the future.

When the FDA raises a concern about a company’s ability to monitor and report on their products, they’ve got a very serious issue at hand. Don’t let it happen to you. Take this other company’s experience as a reminder to get your own SOPs and systems in order…before the FDA comes for an audit.

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Eugene Sefanov

Director, Industry and Regional Marketing

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