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July 6, 2015

Rare Pediatric and Neglected Tropical Diseases: FDA Responds With Guidance

Capitol Hill asks for a lot of things in legislation, and federal agencies eventually do respond. The FDA issued reactions recently to two requests made in bills enacted prior to the current Congress.

Several years ago, in a drug approval reauthorization bill, Congress called on the FDA to devise a strategy to enhance the development of new drugs to patients – particularly children – with rare diseases. On Tuesday, the FDA released its strategic plan for rare pediatric diseases.

Separately, the 2010 Agriculture-FDA spending bill called on the agency to issue guidance on developing drugs for the treatment and prevention of neglected tropical diseases. The FDA late last week issued guidance to industry stakeholders on developing treatments for use in developing countries.

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