FDA+ roundup: CDER's break­through des­ig­na­tion re­quests see steep de­cline in 2021; Drug­mak­ers call to ex­pand FDA guid­ance on PD-(L)1 dos­ing

The once nev­er-end­ing rise of break­through des­ig­na­tion re­quests at the FDA slowed again in 2021, with just over 100 re­quests com­ing in­to the agency, com­pared …

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