Food and Drug Administration

  • “(g) Regulation of combination products; (4)(A) Not later than 60 days after October 26, 2002, the Secretary shall establish within the Office of the Commissioner of Food and Drugs an office to ensure the prompt assignment of combination products to agency centers, the timely and effective premarket review of such products, and consistent and appropriate postmarket regulation of like products subject to the same statutory requirements to the extent permitted by law. (F) The Secretary, acting through the Office, shall review each agreement, guidance, or practice of the Secretary that is specific to the assignment of combination products to agency centers and shall determine whether the agreement, guidance, or practice is consistent with the requirements of this subsection.”

    (21 U.S.C. ­§ 353. Title 21: Food and Drugs. Federal Food, Drug, and Cosmetic Act. Drugs and Devices. Exemptions and consideration for certain drugs, devices, and biological products.)

  • “(h) Guidance of documents; (3) The Secretary, acting through the Commissioner, shall maintain electronically and update and publish periodically in the Federal Register a list of guidance documents. All such documents shall be made available to the public.”

    (21 U.S.C. ­§ 371. Federal Food, Drug, and Cosmetic Act. General Authority. General Administrative Provisions. Regulations and hearings.)

  • “(a) In general; The Secretary, acting through the Commissioner of Food and Drugs, shall automate appropriate activities of the Food and Drug Administration to ensure timely review of activities regulated under this chapter.”

    (21 U.S.C. ­§ 379d. Title 21: Food and Drugs. Federal Food, Drug, and Cosmetic Act. General Authority. General Administrative Provisions. Automation of Food and Drug Administration.)

  • “(2) General powers; The Secretary, through the Commissioner, shall be responsible for executing this chapter and for—(A) providing overall direction to the Food and Drug Administration and establishing and implementing general policies respecting the management and operation of programs and activities of the



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