FDA un­veils list of al­ter­na­tive ways to com­ply with cGMP re­quire­ments for com­bo prod­ucts

The 21st Cen­tu­ry Cures Act, passed dur­ing the Oba­ma ad­min­is­tra­tion in 2016, fea­tured a whole host of changes that were meant to help the biotech sec­tor and help the FDA adapt to some new­er ad­vance­ments in the de­vel­op­ment of drugs.

One of the pro­vi­sions in the bill re­quires the FDA to pro­duce a list of al­ter­na­tive or stream­lined mech­a­nisms to help com­bo prod­uct de­vel­op­ers bet­ter com­ply with cur­rent good man­u­fac­tur­ing prac­tice (cGMP) re­quire­ments.

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