US FDA to boost number and speed of warning letters
This article was originally published in Scrip
The US FDA is making changes to its enforcement practices that will increase the number and timeliness of warning letters and spur quicker enforcement actions following inspection deficiencies.
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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.
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.
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.