1. Pink Sheet

Post-Marketing Progress: Drug Industry Is Meeting Phase IV Commitments, FDA Says

 
• By Kate Rawson

FDA’s John Jenkins disputes accusations that the pharmaceutical industry does not take post-marketing studies seriously and that the agency is lax on enforcement. According to updated data from FDA, Phase IV studies are being completed in a timely manner, Jenkins argues – and when they aren’t, the agency is taking action.

FDA Office of New Drugs Director John Jenkins, MD, wants to correct what he says is a persistent “urban legend” about pharmaceutical regulation: that drug companies don’t complete most of their post-marketing commitments—and that FDA is lax in making sure they do.

“The urban legend is really hard to stamp out, no matter how much data you have,” Jenkins said at The...

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