Adds a new section 1015 ("Abraham Accords Office") to Chapter X of the Federal Food, Drug, and Cosmetic Act establishing an Abraham Accords Office within the Food and Drug Administration, defining "Abraham Accords country," specifying duties, requiring consultation for locating and establishing the office, and requiring a report to Congress.

Amends subsection (d) of 21 U.S.C. 355c to (a) replace paragraph (1) lead-in text ('Beginning 270') with a header 'Noncompliance letter.—', (b) replace paragraph (2) lead-in text with header 'Effect of noncompliance.—' and modify the exception so a drug or biological product is subject to action under section 303 only if the person demonstrated a lack of due diligence, (c) add a limitation preventing issuance of section 303 enforcement actions for failures under this subsection for drugs or biological products that are no longer marketed, and (d) add a new paragraph (4) 'Due diligence' requiring issuance of a noncompliance letter, a 45-day response period from receipt of the letter, and review to determine whether the person demonstrated a lack of due diligence.

Amends 21 U.S.C. 333(f)(4)(A) by adding '505B' to the list of provisions in the cited phrase.

Multiple amendments to section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c): (1) redesignates certain subparagraphs of subsection (a)(3); (2) replaces the existing subparagraph (A) of subsection (a)(3) with a new definition of a 'molecularly targeted pediatric cancer investigation' and adds additional specific requirements and limitations (design requirements, limitation on when combination investigations may be required, authority to require submission of completed preclinical study results with the initial pediatric study plan, and rule of construction regarding inactive ingredients); (3) adds a rule of construction to subsection (a)(1) stating that applications subject to subparagraph (B) are not subject to subparagraph (A) and vice versa; (4) adds a requirement to subsection (e)(1) that the Secretary must determine whether subparagraph (A) or (B) applies before the date the applicant is required to submit the initial pediatric study plan; and (5) makes conforming edits in subsection (a) to update cross-references and phrasing (striking and replacing certain phrases in paragraph (3) as redesignated).

Amends section 372 of the Public Health Service Act (42 U.S.C. 274) by (1) making formatting and punctuation edits in subsection (b)(2); (2) replacing the phrase 'twenty-four-hour telephone service' with '24-hour telephone or information technology service'; (3) adding new subparagraphs (P) and (Q) to subsection (b)(2) to encourage integration of electronic health records via APIs (and successor technologies) and to consider establishing a transplant dashboard; and (4) adding a new subsection (d) authorizing the Secretary to collect registration fees from Organ Procurement and Transplantation Network members to support Network operations, specifying collection/distribution rules, transparency posting and quarterly updates, a GAO review and report within 2 years, and a 3-year sunset on the fee authority.

Strikes the text beginning at the word "section," through the period at the end of the paragraph and inserts a funding specification of $5,000,000 for each of fiscal years 2026 through 2028.

Replaces the existing expiration language in paragraph (5) of 21 U.S.C. 360ff(b) with a new expiration date of September 30, 2029.

Strikes current subparagraph (A) of 21 U.S.C. 360ff(c)(4) and inserts new subparagraph (A) specifying the timing for payment of the priority review user fee (due upon submission of the human drug application for which the voucher is used) and stating all other user fees are due as required by the Secretary or applicable law.

Replaces references to 'same disease or condition' (and similar phrasing) with wording focused on the 'same approved use or indication' or 'same use or indication for which the already approved or licensed drug was approved or licensed', and adds a new definition of 'approved use or indication' specifying approval under section 505 or licensure under section 351 of the Public Health Service Act.

Amends Section 508(b) of the Food and Drug Administration Safety and Innovation Act (21 U.S.C. 355c–1(b)) by (1) adjusting punctuation/wording in paragraphs (11), (15), and (16) and (2) adding a new paragraph (17) that requires the report to include a listing of penalties, settlements, or payments under 21 U.S.C. 353 for failures to comply with requirements under section 505B, including for each penalty/settlement/payment the drug name, sponsor, and amount.