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In the News: October Regulatory and Development Updates

Camargo

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances.

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Pioneering access to complex generic products 

Drug Discovery World

Originator pharma companies are developing ever more complex products, which are transforming the medical landscape, but their cost places an increasing burden on healthcare budgets worldwide. In the meantime, the absence of generics is costing payors and patients billions of dollars in unnecessary additional healthcare expenditure.