The Senate Health Committee will evaluate the science and law of follow-on biologics, Health Policy Staff Director Northrup says. Although the committee's work is in the early stages, congressional action, not a "regulatory or administrative fiat" from FDA, is the next step.
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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.’
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.
