FDA office probed over pending drug applications

MANILA, Philippines — The Anti-Red Tape Authority (Arta) wants an office under the Food and Drug Administration (FDA) to explain why “hundreds of drug applications” have not been approved despite the submission of complete requirements by the pharmaceutical companies.

Arta issued a show-cause order against the FDA Center for Drug Regulation and Research on May 11, after the drugmakers complained against the delay in the approval of their applications “filed as far back as 2014.”

—Roy Stephen C. Canivel