Topic: regulatory approvals
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.
The gene silencing pioneer expects to complete the submission by the end of the year, setting it up to win approval in the U.S. in 2018.
Akcea sees the filing positioning it to bring the treatment of familial chylomicronemia syndrome to market in the U.S. next year.
Regulators stand accused of waving through drugs on the basis of slight data and then failing to ensure postapproval trials validate the decision.