MDMA (Medical Device Manufacturers Association) takes FDA to task over patient safety on SUDs (single use medical devices) issue
This article was originally published in Clinica
The Medical Device Manufacturers Association (MDMA) has accused the US FDA of failing to take appropriate steps to protect patient safety with its regulatory scheme for reused single use medical devices (SUDs).
You may also be interested in...
Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.
Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.
Results of Study to Assess Statin Residual Risk with Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia “should prompt reconsideration of [OTC] mixed omega-3 fatty acid products for [atherosclerotic cardiovascular disease] prevention,” say cardiologists in an editorial published with JAMA study.