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New FDA safety website spotlights when drugs show no problems

This article was originally published in Scrip

Executive Summary

The US FDA opened a new website on 15 June that provides the public updated information on drug safety with a major difference: unlike other FDA safety notification systems, this one spotlights not only reasons for caution, but also the far more frequent instances when a new drug has been found to have no unexpected safety concerns. The site is designed to be accessed by the general public as well as healthcare professionals.

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Clouds had seemed to hover over ThromboGenics ophthalmologic drug ocriplasmin earlier this week when the USFDA staff expressed worries about the extent of adverse events reported in the two Phase III trials supporting its biologics license application (BLA). But they were substantially dispersed on July 26 when the agency's panel of outside advisors voted unanimously that its benefits outweigh its risks. The solid endorsement came despite the fact that, minutes before the decision, three of the 10 committee members had said that the federal regulator should demand new safety studies before approving the intravitreal injection, intended to treat symptomatic vitreomacular adhesions (sVMA) including macular hole.

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The USFDA ophthalmic drugs advisory committee did more than recommend that the agency approve the pending biologics license application (BLA) from Roche's Genentech arm to add to the label for Lucentis (ranibizumab) a new indication for the treatment of diabetic macular oedema (DMO). The outside experts aggressively cheered the drug.

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