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Negotiations Continue On Pediatric Device Reauthorization Provisions

Lawmakers in the House and Senate are still hammering out language to allow companies to continue to profit on humanitarian device exemptions with pediatric indications, and to reauthorize a grant program for non-profit pediatric device consortia.

Lawmakers have yet to settle on language to reauthorize multiple FDA pediatric provisions that expire this September in the lead-up to House and Senate markup sessions this week.

Two device pediatric provisions need to be reauthorized this year to continue: a profit allowance for products that are approved via humanitarian device exemption and include a pediatric indication, and...

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