A thousand physicians call on FDA to reverse CRL for myopia drug

Much of the concern about FDA’s shifting regulatory requirements has focused on orphan drugs, but the agency is also coming under scrutiny for rejecting a therapy for a highly prevalent condition, pediatric myopia.

More than a thousand physicians endorsed a Citizen Petition submitted to the agency Wednesday asking it to reconsider its complete response letter to Sydnexis Inc. for SYD-101, a pediatric myopia treatment...