BILLS-118hr9938ih.pdf

later than 180 days 180 days later than 2 years 14 days 6 days 2-year U.S.C. 351 9938 13 days 46 of title 45 later than 30 days 5 year of the date later than 45 days 12 year OCTOBER 4, 2024 December 8 years

the ‘‘Promising Pathway the ‘Common Rule’ SESSION H. R. 9938 IH sor

9938 IH 9938 IH SEC the United States of America IH California

the Public Health Service Act the Federal Food, Drug GENERAL.—If Congress CONDITIONAL the Committee on Energy U.S.C. the Food and Drug Homeland Federal Regulations ICAL FDA AUTHORITY State PROGRAMS.—A the Office of New 19 Drugs House of Representa- TIONAL Food the Office of Therapeutic Products THE HOUSE OF REPRESENTATIVES Federal Food, Drug Real-World Data’ ditionally Drug Administration Senate DRUGS.—A SEC

kjohnson MIKE GARCIA WESTERMAN

conditional drug approval rare pathway sponsor rare disease drugs cosmetic act drug cosmetic federal food cosmetic substantial designations phase