FDA's von Eschenbach bids adieu ... for now
This article was originally published in Scrip
Do not expect US FDA commissioner Dr Andrew von Eschenbach to retire quietly to the local golf course or his favourite fishing hole after officially departing the agency on January 20th. The 67-year-old commissioner told a press briefing last week that although he does not know what the future holds beyond the FDA, he intends to remain active in bettering the health of others.
You may also be interested in...
With an eye toward addressing uncertainty as to whether patents that cover drug products’ device components or risk management elements should be listed, the agency seeks input on the need for additional clarity around the types of patents that must be submitted and the impact of any change in listing practices on drug development.
La Jolla’s formulation appears blocked by Amivas’ seven-year orphan exclusivity, and the company also will miss out on chance for a tropical disease priority review voucher; Amivas worked with the US Army to bring the severe malaria treatment through final stages of development and regulatory review.
Amivas requested a US tropical disease PRV for intravenous artesunate but FDA has not yet made a decision on eligibility; approval appears to block La Jolla’s competing product, currently under review, for seven years.