Neglected Tropical Disease Designation Rejected For First Time By US FDA
Pneumocystis pneumonia was determined to not meet criteria for a neglected tropical disease that could win sponsors of a new treatment a priority review voucher; FDA made four other diseases eligible.
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Drugs From Sponsors ‘Located in Russia,’ Would Be Barred From US FDA Review By House Funding Bill
Language of the amendment cleared by appropriators in response to the Russian war against Ukraine in FDA’s fiscal year funding bill is vague, making impact of the funding ban on industry unclear. Democrats supported the amendment but said they wanted to continue to work on language to avoid “unintended consequences.” FDA would get a 10% bump in non-user fee funds under the bill.
Sickle Cell Disease Should Qualify For Tropical Disease Priority Review Voucher, Group Says
In citizen petition to US FDA, rare diseases nonprofit group asks agency to add sickle cell disease to its tropical disease PRV list since the disease predominantly impacts those who live in Africa and the African American population in the US.
Priority Review Voucher Eligibility List Gains Three Tropical Diseases
US FDA adds brucellosis, opisthorchiasis and paragonimiasis to the list of qualifying diseases but declines to include clonorchiasis and coccidioidomycosis, finding a significant market in developed nations for treatments or vaccines addressing the two conditions.