PDU­FA VII: FDA and in­dus­try set pri­or­i­ties in first round of ne­go­ti­a­tions

Af­ter kick­ing off the PDU­FA reau­tho­riza­tion process in Ju­ly, the FDA has re­leased the first set of meet­ing sum­maries in its on­go­ing ne­go­ti­a­tions with in­dus­try that will shape its pre­scrip­tion drug re­view pro­gram from FY2023-2027.

The meet­ing sum­maries, while brief, pro­vide in­sights in­to what FDA and in­dus­try hope to get out of the mul­ti-bil­lion-dol­lar agree­ment, with rep­re­sen­ta­tives from gov­ern­ment and in­dus­try alike agree­ing that the ex­plod­ing field of ad­vanced bi­o­log­ic ther­a­pies must be a pri­or­i­ty. In some oth­er ar­eas, though, the wish lists di­verged.

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