Temporary Deferment of Activities Relating to Certain Biologics Submissions

الملخص

The Food and Drug Administration (FDA) is announcing that the Center for Biologics Evaluation and Research (CBER) will be converting its current biologics license application (BLA) data base system into a new data base system. During the period required for this conversion, the agency will temporarily defer certain submissions subject to CBER review and approval, and the review period, if any, on pending submissions will be suspended. FDA plans to temporarily defer action on submissions related to BLA's, product license applications (PLA's), establishment license applications (ELA's), and any related correspondence. FDA is also requesting that sponsors voluntarily refrain from filing the affected submissions during this period. FDA estimates that the deferment period will be about 1 month.