Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

CDER di­rec­tor on ac­cel­er­at­ed ap­proval re­forms and a court de­ci­sion that will 'send a chill' across rare dis­ease drug de­vel­op­ment

At the sec­ond of two hear­ings be­fore the Sen­ate Health, Ed­u­ca­tion, La­bor & Pen­sions Com­mit­tee on the must-pass leg­is­la­tion (by the end of Sep­tem­ber) re­gard­ing the funds from bio­phar­ma in­dus­try ap­pli­ca­tions that will keep the FDA afloat over the next five years, CDER di­rec­tor Pa­trizia Cavaz­zoni raised par­tic­u­lar con­cerns about a re­cent court de­ci­sion while lay­ing out sev­er­al re­quests for con­gres­sion­al ac­cel­er­at­ed ap­proval re­forms.

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