FDA looks to expand pediatric coverage

WASHINGTON - The pediatric exclusivity provision of the FDA Modernization Act (FDAMA) has been a great success and it should be reauthorized before it sunsets next Jan. 1, according to a report FDA has submitted to Congress. The agency also is recommending that Congress increase incentives for testing pediatric indications for off-patent and low-selling drugs as well as for very young children.

FDAMA, which was passed

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