FDA Aims Neglected Tropical Disease Guidance At Inexperienced Sponsors
This article was originally published in PharmAsia News
Big pharma is not the prime player in the tropical disease area, even as some large firms increase funding.
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Final rule includes a total of 21 pathogens, but agency notes a drug intended to treat a pathogen on the list is not guaranteed a QIDP designation for priority review and potential added marketing exclusivity.
By taking into account the incremental costs of priority review and eliminating the IND aspect of the calculation, the agency reduces the fee to redeem a tropical disease priority review voucher to $3.6 million in fiscal year 2013.
FDA indicates it expects sponsors and other government agencies to come up with ways to fulfill its request for placebo-controlled studies post-emergency use authorization of COVID-19 vaccines, but neither it nor vaccines advisory committee see a clear way to do this.