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High price of Mallinckrodt’s H.P. Acthar Gel is important factor in conclusion, HHS Office of Inspector General advisory opinion notes.
This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Sponsors are being invited to trial a new fast-track system for authorizing clinical trials as part of French preparations for the new EU trial rules that are set to come into force in 2020.
But sponsors should sometimes seek advisory comment. Agency explains that most drug-use-related apps will be considered promotional labeling. FDA seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-focused software.
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