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FDA: Ivermectin still not an over-the-counter drug - Vimarsana News

FDA: Ivermectin still not an over-the-counter drug

endIndex: Metro Manila (CNN Philippines, May 11) — Despite being allowed for human consumption, the anti-parasitic drug ivermectin must not be treated as an over-the-counter drug, the Food and Drug Administration warned Tuesday. "It is a prescription drug so a doctor has to prescribe it to you," FDA Director General Eric Domingo told CNN Philippines' The Source. "Kailangan nireseta, kailangan i-explain sa iyo ng doctor kung ano yung gamot na nireseta sa yo, kung ano ang side effect nito, and why it’s being given to you. It’s not an over-the-counter drug," he stressed. [Translation: It ...

ARTA calls out FDA anew for sitting on over 600 applications - Vimarsana News

ARTA calls out FDA anew for sitting on over 600 applications

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 pharma...

Source: mb.com.ph
FDA official asked to explain 600 pending drug applications - Vimarsana News

FDA official asked to explain 600 pending drug applications

FDA official asked to explain 600 pending drug applications enablePagination: false endIndex: 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 co...

DOH to file EUA application for Sinopharm's COVID-19 vaccine - Vimarsana News

DOH to file EUA application for Sinopharm's COVID-19 vaccine

By JULIA MARI ORNEDO, GMA News Published May 10, 2021 12:39pm The Department of Health (DOH) on Monday said it will file an application for emergency use authorization (EUA) of the coronavirus vaccine developed by Chinese firm Sinopharm. “The reason why we are doing this is merong posibilidad na magiging government to government ang transaksyon o negotiations for Sinopharm (there is a possibility that the negotiations for Sinopharm will be government to government),” Health Undersecretary Maria Rosario Vergeire said in an online briefing. “This is something that we do so that we ...

Sotto welcomes FDA approval of ivermectin sale, distribution - Vimarsana News

Sotto welcomes FDA approval of ivermectin sale, distribution

Senate President Vicente ‘Tito’ Sotto III “It removes the claim of some that the drug is illegal,” Sotto said in message to the Manila Bulletin on Saturday, May 8. FDA director-general Eric Domingo, however, clarified that the CPR issued to a pharmaceutical firm classifies ivermectin as an “anti-nematode drug”, or for expelling parasitic worms. He did not mention its approval for treating or preventing novel coronavirus disease (COVID-19). Some lawmakers and doctors have strongly advocated for the use of ivermectin against COVID-19 despite the lack of medical studies proving its e...

Source: mb.com.ph