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FDA awaits application of makers of vaccines against avian flu, ASF

The government’s bid to secure jabs against avian influenza (AI) and African swine fever (ASF) is stuck in limbo as it has yet to receive applications for product registration from vaccine makers, according to the Food and Drug Administration (FDA). “In our current database, we are not evaluating avian flu… ....

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PBBM orders FDA to streamline drug regulatory process, create 'pharma zones' for cheaper medicines

To make affordable drugs more accessible to the public, the Food and Drug Administration (FDA) will be streamlining the application process for new generic drugs along with the establishment of “pharma zones.” In a news conference at the Palace Tuesday, FDA Director General Samuel A. Zacate announced they would be issuing… ....

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ARTA recommends filing of charges vs FDA official

The Anti-Red Tape Authority (ARTA) has endorsed to the Office of the Ombudsman the filing of 412 counts of charges against the head of the Food and Drug Administration – Center for Drug Regulation and Research (FDA – CDRR) for sitting on hundreds of Automatic Renewal (AR) drug applications as far ba ....

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ARTA closely watching FDA official for 'red tape' – Manila Bulletin

Despite the release of approval on hundreds of applications kept for years in her office, the Food and Drug Administration official is not yet off the hook.

Anti Red Tape Authority (ARTA) Director General Jeremiah Belgica said his office is now evaluating the reply of Jesusa Joyce N. Cirunay, Di ....

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ARTA gives FDA ultimatum until May 24

Published May 17, 2021, 3:43 PM
The Food and Drug Administration (FDA) was given until next week, May 24, by the Anti Red Tape Authority (ARTA) to explain for sitting down on hundreds of drug applications from various pharmaceutical companies with complete requirements since 2013.
On May 10, ARTA issued a Show Cause Order to the FDA Center for Drug Regulation and Research (CDRR) after some pharmaceutical companies filed over 20 affidavits detailing the alleged delays of the office in approving their applications that were filed as far back as 2013 or so. ARTA said these involved over 400 pending applications, mostly from Philippine pharmaceutical companies, for automatic renewal. ....

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