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Zdrowie i gospodarka · 29.01.1996

Product and Establishment License Applications, Refusal to File; Meeting of Oversight Committee; Cancellation

The Food and Drug Administration (FDA) is announcing cancellation of the meeting for January 1996 of its standing oversight committee (the committee) in the Center for Biologics Evaluation and Research (CBER) that conducts a periodic review of CBER's use of its refusal to file (RTF) practices on product license applications (PLA's) and establishment applications (ELA's). The meeting is being cancelled because there were no RTF actions taken by CBER in the previous quarter. CBER's RTF oversight committee examines all RTF decisions which occurred during the previous quarter to assess consistency across CBER offices and divisions in RTF decisions.

Source: Federal Register — Food and Drug AdministrationOpen original release →