FDA should specify that ANDAs which change certification from Paragraph III to Paragraph IV should trigger for a 30-month stay, the Pharmaceutical Research & Manufacturers of America states in comments on FDA's proposed rule
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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.’
US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.
In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.
