FDA Details Structure Of Drugmakers' Pediatric Study Plans

Law360, New York (July 12, 2013, 7:13 PM EDT) -- The U.S. Food and Drug Administration on Friday described how drugmakers can comply with a new requirement that they detail their plans for studying new medicines in children at an early stage of product development, laying out the required timing and content of such submissions.

In draft guidance, the FDA offered specifics on what is expected of so-called initial pediatric study plans, or PSPs, which under last year's user-fee law must be provided to the FDA while drugs are still being studied.

The mandate applies to...
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