D.C. Circuit Says Drug Maker Did Not Show Error In FDA’s Refusal To Reclassify

(July 29, 2024, 2:24 PM EDT) -- WASHINGTON, D.C. —The U.S. Food and Drug Administration did not violate the Administrative Procedure Act (APA) by refusing to reclassify a company’s drug as a biological product, which makes approval of a generic product more difficult, the District of Columbia Circuit U.S. Court of Appeals said in an opinion unsealed July 26, affirming a lower court’s summary judgment award in favor of the FDA and the drug company’s competitor....