Zdrowie i gospodarka · 22/06/2000

FDA Temporarily Deferment of Activities Relating to Certain Biologics Submissions

The FDA is temporarily deferring certain biologics submissions and suspending review periods for submissions related to biologics license applications (BLA's), product license applications (PLA's), and establishment license applications (ELA's) due to a conversion of its database system. The agency estimates a one-month deferment period and requests that sponsors voluntarily refrain from filing affected submissions during this time.