Examples of FDCA in a sentence
The Company and each of its subsidiaries have not, for the past five (5) years, received any written notice of adverse filing, warning letter, untitled letter or other written correspondence or written notice from the FDA, or any other court or arbitrator or federal, state, local, or foreign governmental or regulatory authority, alleging or asserting material noncompliance with the FDCA.
Second, the Xxxxx-Xxxxxx amendments to the FDCA also established a statutory procedure for submission and FDA review and approval of abbreviated new drug applications (“ANDAs”) for generic versions of branded drugs previously approved by the FDA (such previously approved drugs are referred to as “listed drugs”).
By signing this Agreement, you hereby represent, warrant and certify that you have not been debarred under the FDCA (21 U.S.C. 335a), excluded from a government health care program (including, but not limited to, Medicare or Medicaid), or convicted of any offense required to be listed under Section 306(k)(2) of the FDCA; nor are you, to the best of your knowledge, the subject of any pending proceeding which may result in such debarment, exclusion or conviction.
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and related regulations.
First, the Xxxxx- Xxxxxx amendments to the FDCA authorized the FDA to approve an alternative type of NDA under Section 505(b)(2) of the FDCA.