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.
Document
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...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
80 FR 31048
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“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.