"Standard" Coronary Stent Trials Should Use PMA Data From Past Trials
This article was originally published in The Gray Sheet
Executive SummaryCoronary stent manufacturers with products already approved by FDA might consider releasing data contained in their premarket approval applications to serve as a replacement for the control arm for certain coronary stent trials, provided firms receive some level of compensation for the data and a certain amount of control over how they are used.
You may also be interested in...
Emerging Company Profile: Axcella uses Generally Recognized As Safe (GRAS) amino acids to create drug candidates for hepatic encephalopathy, NASH and other diseases.
A reagent in a batch of COVID-19 tests shipped by the US Centers for Disease Control and Prevention to state laboratories “wasn’t performing consistently,” a top CDC official says, so the agency is reformulating it – slowing down the labs’ ability to use the diagnostic, which yielded inconsistent results when quality-tested. But waiting in the wings are commercial coronavirus test kits being developed by Qiagen and Cepheid; both firms say they’ll submit the kits to the FDA for emergency-use approval.
OIG will focus on successful drugs that have been repurposed as orphans, noting nine of the 10 top selling drugs have both orphan and non-orphan indications.