FDA+ roundup: Leg­isla­tive asks for 2024 fo­cus on more au­thor­i­ties, gener­ic drug com­pe­ti­tion

The FDA’s leg­isla­tive pri­or­i­ties for the next year high­light the agency’s fo­cus on ex­pand­ing gener­ic drug com­pe­ti­tion, back­stop­ping the sup­ply chain and grow­ing its cur­rent au­thor­i­ties.

On the new au­thor­i­ties front, FDA is seek­ing to ex­pand its manda­to­ry re­call au­thor­i­ty for all drugs, as the agency has been em­broiled in a long process to re­move some from the mar­ket. Co­vis Phar­ma re­fused to pull its preterm birth drug Mak­e­na, which won ac­cel­er­at­ed ap­proval, for al­most five years af­ter fail­ing its con­fir­ma­to­ry tri­al. The com­pa­ny has since re­versed course af­ter a neg­a­tive ad­comm.

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