What in the world is a MI­NOR CRL, Am­phastar?

For­mer FDA com­mis­sion­er Scott Got­tlieb once flirt­ed with the idea of il­lu­mi­nat­ing redact­ed ver­sions of com­plete re­sponse let­ters (CRLs), al­though his in­ter­est in do­ing so even­tu­al­ly waned. Had that ini­tia­tive been im­ple­ment­ed — we may have un­der­stood ex­act­ly what Am­phastar meant when it is­sued a press re­lease char­ac­ter­iz­ing the re­jec­tion let­ter it re­ceived for its for­mu­la­tion of ep­i­neph­rine as a “mi­nor” CRL.

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