jueves, 4 de enero de 2018

Summary of REMS@FDA website updates for December, 2017

Summary of REMS@FDA website updates for December, 2017
The FDA's REMS website, REMS@FDA, has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):  
1.  Emtricitabine/tenofovir disoproxil fumarate Shared System REMS modified 12/08 to change the graphics for the SSS REMS educational materials, including a change in color scheme and removal of Truvada brand elements. 
 2.  Myalept (metreleptin) REMS modified 12/11 to revise prescriber training materials to highlight the risk of developing severe infections and the availability of testing for anti-metreleptin neutralizing antibodies if severe infections occur, and and the addition of a new communication plan which includes a new REMS letter to currently certified prescribers to inform them of the availability of updated training materials.

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