Topic: regulatory approvals
Illumina received its first official approval in China for its MiSeqDx benchtop sequencer, allowing it to directly market NGS testing in the country.
The FDA approved Endomag’s nonradioactive, magnetic, liquid tracer for mapping lymph nodes in breast cancer patients undergoing mastectomy.
Medtronic and United Therapeutics received approval for a fully implantable infusion pump filled with Remodulin for pulmonary arterial hypertension.
Gottlieb thinks revisions are needed to give the FDA authorities that are a better fit for modern diagnostics than the current 510(k) pathway.
Drugmakers cannot file regulatory submissions that require the payment of a fee until politicians pass a bill to fund the federal government.
The FDA has committed to making the U.S. market a top priority for more than 50% of developers of novel devices by the end of 2020.
Gottlieb talked up the prospect of releasing redacted CRLs in his confirmation hearings but has now watered down his interest in the idea.
The panel felt Aradigm failed to show evidence of the safety and efficacy of Linhaliq in delaying the first exacerbation in chronic lung infections.
The panel voted 13-6 against the risk-benefit profile of Tlando, leaving Lipocine looking at a rejection.
Biom’Up said the FDA signed off on marketing its Hemoblast Bellows hemostatic product designed to control bleeding during surgery.