FDA Announces Changes to Review Committee Meetings for New Drug Applications

Summary

The Food and Drug Administration (FDA) is modifying its review process for new drug applications (NDA's) that are deemed deficient, allowing the Center for Drug Evaluation and Research (CDER) to review all refusal to file (RTF) decisions, eliminating the need for applicants to submit requests for review, starting from January 1994 when the committee switched from quarterly to bi-monthly meetings.