May 11, 2021

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ARTA issues show-cause order to FDA drug center over inaction on drug applications

THE Anti-Red Tape Authority (ARTA) issued a show-cause order to the Food and Drug Administration’s (FDA) drug testing center for alleged inaction on more than 600 drug applications.

In a statement Tuesday, ARTA confirmed that Investigation Enforcement and Litigation Director Jedrek C. Ng sent the order to the FDA’s Center for Drug Regulation and Research Director Jesusa Joyce N. Cirunay.

ARTA said the show-cause order was a result of 23 affidavits of various pharmaceutical firms that detailed the alleged delays, some involving applications filed starting 2014.

ARTA Director General Jeremiah B. Belgica said the applications are not considered complex — one of the standards that allow for extended review. — Revin Mikhael D. Ochave

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