Notice of Decision Not To Designate Pneumocystis Pneumonia as a Tropical Disease

الملخص

The Food and Drug Administration (FDA or Agency), in response to suggestions submitted to Docket No. FDA-2008-N-0567, has analyzed whether Pneumocystis pneumonia (PCP) meets the statutory criteria for designation as a tropical disease for the purposes of obtaining a priority review voucher (PRV) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), namely whether it primarily affects poor and marginalized populations and whether there is "no significant market" for drugs that prevent or treat PCP in developed countries. The Agency has determined that PCP does not meet the statutory criteria for designation as a tropical disease and declines to designate it as such.