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Clozapine REMS deadlines for prescribers and pharmacies extended
Publication year - 2016
Publication title -
the brown university psychopharmacology update
Language(s) - English
Resource type - Journals
eISSN - 1556-7532
pISSN - 1068-5308
DOI - 10.1002/pu.30110
Subject(s) - certification , clozapine , pharmacy , authorization , medicine , food and drug administration , health care , medical emergency , process management , business , computer security , computer science , nursing , schizophrenia (object oriented programming) , psychiatry , political science , law , economics , economic growth
Due to ongoing implementation challenges with the new Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program (see the December 2015 issue of The Update ), the Food and Drug Administration is extending the Nov. 23, 2015, prescriber certification deadline and the Dec. 14, 2015, pharmacy certification deadline to help ensure that health care professionals have sufficient time to complete this process and that patient access to clozapine is maintained. The FDA is also carefully evaluating next steps regarding the Dec. 14, 2015, pre‐dispense authorization (PDA) launch. The FDA will communicate the revised certification deadlines and additional information about the PDA launch as soon as possible.