§ 5.93 - Submission of and effective approval dates for abbreviated new drug applications and certain new drug applications.

The following officials are authorized to perform all of the functions of the Commissioner of Food and Drugs with regard to decisions made under section 505 (c)(3)(D), (j)(4)(B)(iv), and (j)(4)(D) of the Federal Food, Drug and Cosmetic Act (the act) concerning the date of submission or the date or effective approval of abbreviated new drug applications including supplements thereto submitted under section 505(j) of the act and of new drug applications including supplements thereto submitted under section 505(b)(1) of the act and described under section 505(b)(2) of the act:

(a) The Director, Deputy Center Director for Review Management, and Deputy Center Director for Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).

(b) The Director and Deputy Director, Office of Generic Drugs, Office of Pharmaceutical Science, CDER.