New Drug Applications; Refusal to File; Change in Schedule of Meetings of the Review Committee

Resumen

The Food and Drug Administration (FDA) is announcing a change in the procedure that the Center for Drug Evaluation and Research (CDER) uses to review its use of its refusal to file (RTF) procedure, by which it refuses to file new drug applications (NDA's) that are facially deficient under FDA's regulations. Since January 1994, the committee has been meeting bi-monthly rather than quarterly. Because the committee will review all RTF decisions rather than only a few, new drug application (NDA) applicants will not need to submit requests for review.