CDER re­leas­es pol­i­cy for han­dling new­ly iden­ti­fied safe­ty sig­nals

The FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) last week is­sued a new man­u­al of poli­cies and pro­ce­dures (MAPP) ex­plain­ing its in­ter­nal process for iden­ti­fy­ing, eval­u­at­ing and re­solv­ing new­ly iden­ti­fied safe­ty sig­nals (NISS) for mar­ket­ed drugs.

FDA says the MAPP is meant to pro­vide a “high lev­el” overview of how and when com­mu­ni­ca­tion re­lat­ed to new­ly iden­ti­fied safe­ty is­sues is trans­mit­ted be­tween dif­fer­ent of­fices and dis­ci­plines with­in CDER. The MAPP ap­plies to safe­ty sig­nals re­lat­ed to ap­proved drugs and bi­o­log­ics, mar­ket­ed yet un­ap­proved drugs, over-the-counter mono­graph prod­ucts, com­pound­ed drugs and med­ical gas­es.

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