New drug approvals continued during the partial government shutdown, as user fees helped keep most of the FDA review functions running smoothly. The drug center did face some unusual challenges, including responding to a major manufacturing shutdown (by Ben Venue) – and to speculation about a leadership change at the drug center.
On October 8, FDA completed the first new drug application review that involved the full implementation of the review procedures adopted by the Prescription Drug User Fee Act for new molecular entities, when it approved Bayer AG’s Adempas (riociguat) for treatment of pulmonary hypertension.
Adempas is not the first application approved under the new “program” for new molecular entity reviews, but it is the...
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.’
The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.
Joshi joins the parent company of Citeline, home of the Pink Sheet, to focus on AI, business harmonization and long-term growth.
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
