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 Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. Section 301 et seq., and all regulations promulgated thereunder.

Examples of FDCA in a sentence

Except as set forth on Schedule 4.19(e), neither any Credit Party nor any of its Subsidiaries has a reasonable expectation that there are grounds for imposition of a clinical hold or a withdrawal of an approved investigational study application, or for the termination of an investigational study, under the FDCA and applicable regulations for Product.
Moreover, each Party covenants that in the event it or any of its employees or Representatives are subsequently debarred under the FDCA or excluded from a federal healthcare program during the Term hereof, it shall notify the other Party within [**] days.

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 United States Federal Food, Drug, and Cosmetic Act, as amended.

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.

FDCA shall have the meaning set forth in Section 2.11(c).