AICD approval for MADIT indication may require supplementary data -- FDA.
This article was originally published in The Gray Sheet
Executive SummaryAICD MADIT POPULATION APPROVAL REQUIRES SUPPLEMENTARY DATA OR ACCESS to raw clinical data from the Multicenter Automatic Defibrillator Implantation Trial, FDA says in a recent letter to manufacturers of automatic implantable cardioverter defibrillators. The letter outlines options for manufacturers seeking supplemental approval of AICDs for the same prophylactic indications received by Guidant based on MADIT data.
You may also be interested in...
Senate Finance Committee’s approach to penalize companies for raising WAC list prices is not a ‘price control,’ but a reasonable approach to change the incentives that distort pricing in the supply chain, US HHS Secretary Alex Azar says.
With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.
February and March inspections deferred unless any are deemed mission critical. China director remains behind as staff evacuate.