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FDA Commissioner Margaret Hamburg and US Assistant Secretary for Health Howard Koh released a statement aimed at a stakeholder meeting being held at the US Department of Health and Human Services to address the growing issue of drug shortages in the United States.

The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission's 2010 amended pharmacovigilance legislation.

Representatives from FDA, the Generic Pharmaceutical Association, the European Fine Chemicals Group, and a task force from the Society of Chemical Manufacturers and Affiliates are nearing completion of draft legislation for the Generic Drug User Fee Act.

Sanofi outlined its long-term financial objectives this week as the company discussed its strategy in mitigating generic-drug incursion and in generating growth in key therapeutic areas and emerging markets.

Knowing is Half the Battle

Being aware of a forthcoming inspection or how a product was made can make a huge difference.