Quick FDA review for depression treatment:
This article was originally published in Clinica
The US FDA has told Cyberonics that it will review the company's premarket approval application for a nerve stimulator to treat depression under expedited review status. The Houston, Texas-based company has yet to start its randomised clinical trial of the NCP system, but has submitted an investigational device exemption with the FDA. The trial is likely to take two to three years to complete, said the company. The NCP device is already sold in the US to treat epilepsy and has proved popular with physicians (see Clinica No 812, p 13).
You may also be interested in...
Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.
US FDA will simultaneously review the vaccines, with Moderna’s advisory committee set a week after Pfizer’s. ACIP emergency meeting scheduled for 1 December with vote likely on distribution priority for health care personnel.
Sabinsa provided FDA and FTC with documentation of “an ingredient falsely marketed and sold as vitamin C derived from amla fruit (Emblica officinalis), which two independent labs have confirmed is actually derived from corn, sugarcane or other plants.”