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

Read the full 665 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE