Device Component Of Intarcia’s Diabetes Treatment ITCA 650 Worries FDA
If FDA chief scientist grants Intarcia’s request for advisory committee meeting, CDER wants to provide input on issues to be considered. Director Cavazzoni says the novel drug-device combination product does not notify the user of a critical failure or infusion status.
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Intarcia, CDER Tussle Over Advisory Cmte. Process For Hearing On Denial Of Diabetes Combo Product
Seeking to reverse CDER’s proposal to reject the NDA, Intarcia wants a say in formulating issues to be presented to the committee and questions inclusion of device experts as ad hoc members that will consider the fate of ITCA 650, a subdermal pump which delivers the GLP-1 agonist exenatide.
Intarcia Gets Chance For AdComm Review Of ITCA 650; Hearing For Sotagliflozin Shot Down
FDA chief scientist encourages Intarcia to request advisory committee review of CDER’s proposal to refuse approval of its drug-device diabetes treatment. CDER again denies Lexicon request for hearing on proposal to deny approval of its SGLT2 inhibitor.
Vanda Objects To FDA’s ‘Highly Prejudicial’ Hearing Process And ‘Extra-Regulatory’ Requirements
Vanda says FDA improperly requires it to disprove all alleged deficiencies in its Hetlioz application for jet lag. Contentious approach to notice of opportunity for hearing contrasts with that of Intarcia and Lexicon, which also seek hearings over FDA’s proposal to refuse their applications.