FDCA definition

FDCA shall have the meaning ascribed to such term in Section 3.1(hh).
FDCA means the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. Section 301 et seq., and all regulations promulgated thereunder.
FDCA means the United States Federal Food, Drug, and Cosmetic Act.

Examples of FDCA in a sentence

  • In doing so, the Plaintiffs must explain in plain terms what constitutes an adulterated drug under the FDCA and whether and how they have put forward evidence that ranitidine was adulterated under that standard.

  • Under the Hatch-Waxman Amendments to the FDCA, a pharmaceutical company may seek expedited approval to sell a generic version of a previously approved drug and thereby avoidthe normally time-intensive and costly drug approval process.

  • Consecutive pagination of the OCA and the Detailed Statement does nothing to make an OCA apply to a paragraph IV notice letter’s detailed statement.Fourth, viewing the OCA and the Detailed Statement as one and the same is inconsistent with the FDCA.

  • Whereas fraud was not a prerequisite for assessing penalties on violators, where fraud could be proved, higher penalties would be applied.The FDCA in §304 (a) provides for the seizure of any food, drug, device or cosmetic in interstate commercethat is adulterated or misbranded.

  • As a result, under the FDCA, the supplements were presumptively “adulterated.” Id. at 1080-81.


More Definitions of FDCA

FDCA shall have the meaning ascribed to such term in Section 3.1(gg). “GAAP” shall have the meaning ascribed to such term in Section 3.1(h).
FDCA means the Federal Food, Drug and Cosmetic Act of 1938, as amended.
FDCA means the Federal Food, Drug, and Cosmetic Act of 1938 and the rules and regulations promulgated thereunder.
FDCA means the Food, Drug and Cosmetics Act, as amended, and the rules and regulations promulgated thereunder.
FDCA means the Food, Drug, and Cosmetic Act, as amended from time to time.
FDCA is defined in Section 4.19(b).
FDCA means the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, and the rules, regulations, guidelines, guidances and requirements promulgated thereunder, as may be in effect from time to time (including all additions, supplements, extensions and modifications thereto).