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.’
ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.
