FDA's top gener­ic drug leader puts in her two weeks as GDU­FA III looms

The FDA is about to lose an­oth­er top leader with the de­par­ture of Sal­ly Choe, di­rec­tor of the FDA’s Of­fice of Gener­ic Drugs, on Oct. 8. The de­par­ture co­in­cides with the tran­si­tion from the sec­ond reau­tho­riza­tion of the Gener­ic Drug User Fee Amend­ments to the third reau­tho­riza­tion, which Con­gress has un­til Fri­day to fin­ish up.

Choe, who didn’t im­me­di­ate­ly say where she’s head­ing post-FDA, but did a stint at Parex­el, has served as the OGD di­rec­tor since Feb­ru­ary 2019, and “has been the prin­ci­pal med­ical and tech­ni­cal au­thor­i­ty on all mat­ters re­lat­ed to gener­ic drug re­view and ad­vised me and oth­er agency of­fi­cials,” CDER di­rec­tor Pa­trizia Cavaz­zoni said in an email to staff an­nounc­ing Choe’s de­par­ture.

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