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FDA inaction on drug applications probed

Republika

For allegedly taking no action for over 600 drug applications submitted by pharmaceutical companies, the Anti-Red Tape Authority (ARTA) has issued a show-cause order against Center for Drug Regulation and Research (CDRR) under the Food and Drug Administration (FDA).

CDRR director Jesusa Cirunay has to explain why her office has no action over the applications even the pharmaceutical companies have submitted complete requirements, ARTA said.


“ARTA’s action stemmed from the 23 affidavits of several pharmaceutical companies detailing the alleged delays committed by FDA-CDRR on their applications filed as far back as 2014 or so,” it said.


ARTA director general Jeremiah Belgica said they found out that these applications are not complicated.


“These are the applications for automatic renewal. These are products that were already used before and they now just want to be registered. Some of the products are low to no risk to people,” Belgica added.


Cirunay is given seven days to reply to ARTA’s show-cause order dated May 11.


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