Development of safety monitoring independent of FDA review divisions urged by Thomas Moore, George Washington University Center for Health Policy Research, et al., in the May 19 JAMA. The "discovery of serious adverse effects not detected in preapproval testing can be unwelcome news to both the drug's sponsor and the FDA division that evaluated and approved the drug," Moore et al. note. The agency's Division of Pharmacovigilance & Epidemiology "is limited to reporting its information and conclusions back to the FDA review division, even if these findings call into question the original decision to approve the drug," Moore et al. say. A 1993 FDA program review by outside consultants called for independent safety monitoring, the article notes, also pointing to the U.K. system, under which product reviews and surveillance are handled by separate offices. Moore was a frequent witness at FDA reform hearings...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.
Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.
Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.
