What facilities produce what drugs for the U.S. market? FDA is committed to obtaining a more accurate answer to that question by requiring electronic registration and listing - and by knocking on doors if necessary. A registration fee could be coming, if pending legislation is any indication. Although the agency has long sought to improve its flawed paper drug registration and listing process, progress is much quicker with Congress reacting to fears of substandard ingredient suppliers in China. Under the new approach, all registered facilities will have unique numerical identifiers called DUNS numbers obtained from Dun & Bradstreet. Meanwhile, FDA is turning to commercial databases to clean up its list of drugs on the U.S. market - and flush out illegal unapproved drugs for targeted enforcement actions.
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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.’
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Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
