Requires the FDA to clarify which pediatric study rules apply to a drug, extends the rare pediatric disease priority review voucher program through September 30, 2029, and creates an Abraham Accords Office within the Food and Drug Administration.

• Requires the FDA to determine which pediatric study requirement applies to a drug before the applicant's initial study plan is due, and gives companies 45 days to respond in writing to a noncompliance letter before a penalty can be imposed for lack of due diligence.
• Extends the rare pediatric disease priority review voucher program through September 30, 2029, and changes the user fee timing for vouchers.
• Limits orphan drug exclusivity so that it applies only to the same approved use or indication, and authorizes $25,000,000 per fiscal year for 2026 through 2028 for pediatric drug studies.
• Establishes an Abraham Accords Office at the FDA to provide technical assistance and facilitate interactions with regulatory partners in Abraham Accords countries, and raises the Medicare Improvement Fund amount from $1,403,000,000 to $2,622,000,000.

• Energy and Commerce Committee (House)

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