Published May 11, 2021, 3:57 PM
The Anti-Red Tape Authority (ARTA) has issued a show-cause order to a Food and Drug Administration (FDA) office for sitting on over 600 drug applications filed since 2014 despite completeness of submission of various pharmaceutical companies.
ARTA Investigation Enforcement and Litigation Director Jedrek Ng on Tuesday, May 11, ordered FDA Center for Drug Regulation and Research (CDRR) Director IV Jesusa Cirunay to “explain why no administrative or criminal case should be filed” against her.
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.
FDA official asked to explain 600 pending drug applications
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Metro Manila (CNN Philippines, May 11) – The Anti-Red Tape Authority issued on Tuesday a show-cause order against a Food and Drug Administration official for 600 drug applications pending in her office.
ARTA ordered FDA Center for Drug Regulation and Research (FDA-CDRR) Director Jesusa Cirunay to explain why the drug applications remain pending despite the complete submission of requirements by involved pharmaceutical firms.
The complaint stemmed from the 23 affidavits of several pharmaceutical companies which detailed the alleged delays committed by FDA-CDRR on their applications filed since 2014.
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Customs seizes 20,000 undeclared ivermectin tablets, other drugs
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Metro Manila (CNN Philippines, May 5) - The Bureau of Customs - Ninoy Aquino International Airport (BOC-NAIA) on Tuesday intercepted 20,000 undeclared ivermectin tablets and other regulated drugs concealed in a shipment from New Delhi, India.
Ivermectin is claimed by some as a possible cure against COVID-19. But health experts said there is not enough proof the antiparasitic drug can treat or prevent coronavirus infection.
For now, the Food and Drug Administration only issues a compassionate special permit to use ivermectin. In case ivermectin has been granted authorization, a valid license to operate as drug importer and emergency use authorization or certificate of product registration shall be presented, FDA Center for Drug Regulation and Research Director Jesusa Cirunay said in her response to the BOC s query.