FDA aims to bet­ter in­cen­tivize qual­i­ty drug man­u­fac­tur­ing in new pro­gram

The FDA on Thurs­day un­veiled its lat­est pro­gram to pro­mote qual­i­ty at drug man­u­fac­tur­ing es­tab­lish­ments, look­ing to push com­pa­nies to go above and be­yond the cur­rent good man­u­fac­tur­ing prac­tice (CGMP) re­quire­ments.

The qual­i­ty man­age­ment ma­tu­ri­ty (QMM) pro­gram ar­rives as the US con­tin­ues to face short­ages of com­mon can­cer drugs and re­ly on for­eign man­u­fac­tur­ers for many of its APIs. Pri­or re­search has shown how the root cause for many drug short­ages “is the ab­sence of in­cen­tives for man­u­fac­tur­ers to strive for more than sim­ply meet­ing CGMP reg­u­la­tions and to de­vel­op ma­ture qual­i­ty man­age­ment sys­tems,” the FDA said.

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