MiniMed/Hoechst plan mid-1997 PMA/NDA submission for implantable insulin pump.
This article was originally published in The Gray Sheet
Executive Summary
MINIMED/HOECHST PREMARKET APPLICATION FOR MIP-2001 INSULIN INFUSION PUMP is slated for filing by mid-1997, according to MiniMed. The Sylmar, California-based company says it has completed a 350-patient, multi-center, prospective study of the device and is waiting for Hoechst to complete stability testing on the concentrated insulin (400 U/mL) used with the pump. The premarket approval application/new drug application, which will be submitted to FDA's Center for Drug Evaluation and Research, will seek an indication for treatment of all Type I diabetes.
You may also be interested in...
Pharma Can Pursue Claims Against Providers For 340B Duplicate Discounts In Medicaid Managed Care, HRSA Says
The statement, which is part of a final rule on the 340B administrative dispute resolution process, could facilitate manufacturer efforts to seek repayments from hospitals in such cases.
The Aspirin Test For AI?
US FDA Commissioner Robert Califf tells Congress that regulators don’t have to know how artificial intelligence works in medicine, but must make very sure it actually does work.
Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire
Clarke helped launch GDUFA I and negotiate GDUFA II, chaired the CDER Executive Committee and oversaw many other programs in the US FDA’s drugs center.