FD&C Act definition

FD&C Act means the United States Federal Food, Drug and Cosmetic Act, as amended.
FD&C Act means the U.S. Food, Drug and Cosmetic Act of 1938, 21 U.S.C. §§ 301 et seq. (or any successor thereto), as amended from time to time, and the rules, regulations, guidelines, guidance documents and compliance policy guides issued or promulgated thereunder.
FD&C Act means the United States Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.) as amended to date together with any rules or regulations promulgated thereunder.

Examples of FD&C Act in a sentence

  • The introduction or delivery for introduction into interstate commerce of this drug product before the final approval date is prohibited under section 301 of the FD&C Act.

  • This drug product may not be marketed without final Agency approval under section 505(j) of the FD&C Act.

  • Also, until the Agency issues the final approval letter, this drug product will not be deemed approved for marketing under section 505(j) of the FD&C Act, and will not be listed in the Orange Book.

  • In particular, under section 506I(b) of the FD&C Act, you are required to notify the Agency in writing within 180 days from the date of this letter if this drug will not be available for sale within 180 days from the date of approval.

  • In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process.


More Definitions of FD&C Act

FD&C Act means the U.S. Federal Food, Drug and Cosmetic Act, as amended.
FD&C Act means the U.S. Food, Drug and Cosmetic Act of 1938 (or any successor thereto), as amended from time to time, and the rules, regulations, guidelines, guidance documents and compliance policy guides issued or promulgated thereunder.
FD&C Act means the Federal Food, Drug and Cosmetic Act, as the same may be amended or supplemented from time to time.
FD&C Act means the United States Federal Food, Drug and Cosmetic Act of 1938, as amended.
FD&C Act has the meaning set forth in Section 3.16(b).
FD&C Act means the United States Federal Food, Drug and Cosmetic Act, as amended from time-to-time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).
FD&C Act means the Federal Food Drug & Cosmetics Act (Title 21, Code of the United States Code of Federal Regulations (CFR) [21 U.S.C.]).