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Patient-Focused Drug Development for Alpha-1 Antitrypsin Deficiency; Public Meeting

The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for Alpha-1 Antitrypsi...

The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for Alpha-1 Antitrypsin Deficiency (AATD). Patient-Focused Drug Development is an FDA performance commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to provide FDA with patients' perspectives on the impact on daily life of AATD. FDA also is seeking patients' perspectives on the available therapies for this disorder.

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80 FR 31048

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“Patient-Focused Drug Development for Alpha-1 Antitrypsin Deficiency; Public Meeting,” thefederalregister.org (June 1, 2015), https://thefederalregister.org/documents/2015-13063/patient-focused-drug-development-for-alpha-1-antitrypsin-deficiency-public-meeting.