Approval and Clearances

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FDA approval of a drug means that data on the drug's effects have been reviewed by CDER, and the drug is determined to provide benefits that

approval noun an act of officially accepting or allowing something: You'll need your parents' approval to take this field trip  approval to market it was commonly taken to mean that approval was not far away In February of 1988 , Wyeth Ayerst contacted the agency with a complaint

onlinegu in Overview of the SAP The Simplified Approval Process is an application process for projects or programmes that are expected to possess significant FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology Please refer to Drugs@FDA for the