Merck’s Postmarketing Study Delays Prompt FDA To Unsheathe New Enforcement Power
Januvia and Janumet are misbranded, FDA tells Merck in a warning letter noting that rodent safety studies for the sitagliptin diabetes drugs were 20 months behind schedule. The letter marks the first time FDA has used its FDAAA powers to take enforcement action against a pharma company for such a delay.
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Changes in legacy DARRTS system, transition to new platform and standardized format for annual report submission should improve FDA's tracking of postmarketing requirements, agency tells Office of the Inspector General.
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.
Agency says Shionogi’s orally disintegrating tramadol is misbranded because the firm did not submit a post-marketing trial protocol in time, but the company states the trial is not worth the expense and will withdraw the product.