Change of address for BLA submissions

Executive Summary

As of Oct. 4, all therapeutic biologic submissions excluding 21 CFR 600.80 postmarketing adverse experience reports; advertising and promotional labeling; and 21 CFR 600.14 biological product deviation reports should be sent to CDER Therapeutic Biological Products Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 12229 Wilkins Ave., Rockville, MD 20852. FDA hopes to continue its normal pace of review, but "I do anticipate that it might slow things down a little bit," CDER Office of Compliance Therapeutics Facilities Review Branch Facility Reviewer Carolyn Renshaw said during the PDA/FDA Regulatory Conference in Washington, D.C. Sept. 22. "There is going to be a transition period. I do believe it will be difficult mailing and getting everything on time, which was difficult to begin with"...