Drug Industry Daily
Jan. 9, 2004
| Vol.
3 No.
5
CBER LISTS PROCEDURES FOR APPLICANTS WHO PROTEST FILING DECISIONS
If the Center for Biologics Evaluation and Research (CBER) refuses to consider a biologics manufacturer’s product application, the firm has 30 days in which to request a meeting to discuss the reasons for refusal.
This article is viewable by subscribers only. To view this article, please select an option below.
|