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 to 156 just two years ago.

In ad­di­tion to the de­cline in re­quests, there was al­so a sub­stan­tial drop off in ap­provals: FDA hasn’t ap­proved this few of re­quests — 41 were grant­ed in FY 2021 — since 2015. And the agency’s 39 de­nied re­quests are the fewest of any year since the break­through pro­gram was cre­at­ed in 2012 by the Food and Drug Ad­min­is­tra­tion Safe­ty and In­no­va­tion Act.

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