FDA, nagpaalala sa tamang pag-iimbak ng alcohol at sanitizer upang makaiwas sa sunog

Robie de Guzman   •   October 1, 2020   •   173

MANILA, Philippines – Nagpaalala ang Food and Drug Administration (FDA) sa publiko hinggil sa wastong pag-iimbak ng rubbing alcohol, sanitizer at iba pang uri ng disinfectant dahil posible umano itong pagmulan ng sunog.

Ayon kay FDA director general Eric Domingo, flammable o madaling masunog ang mga ganitong uri ng materyal dahil sa taglay nitong mataas na antas ng alcohol at iba pang kemikal.

Maliban sa rubbing alcohol at sanitizer, kabilang din sa flammable products na kalimitang nakikita sa bahay ay ang aerosols katulad ng hairspray at anti-perspirant sprays, fabric softener, nail polish remover, cooking oil, at harina.

Ginawa ni Domingo ang paalala sa gitna ng novel coronavirus disease (COVID-19) pandemic kung kailan marami ang gumagamit ng alcohol at iba pang disinfectant upang makaiwas sa COVID-19.

Ayon sa FDA chief, dapat ilagay sa maayos na lugar ang mga bote ng disinfectants at malayo sa apoy o sa mga bagay na may matataas o maiinit na temperatura.

“Gusto natin sa temperature na mababa, hindi pwede sa mainit, wala sa direct na araw. At syempre gusto natin sa mga lugar na maaliwalas, hindi sa mga confined,” ang wika ni Domingo.

“Kapag ganito, may posibility na pwede siyang ma-ignite o masindihan at hindi lang masunog, maaring sumabog,” dagdag pa niya.

Dapat rin aniya ay may maayos na label ang mga produkto at may sapat na babala at impormasyon para sa mga gagamit nito.

“Meron tayong mga labelling requirements na nakalagay. And in fact, pag alcohol, nakalagay diyan may warning na probable o maaaring masunog at of course maaaring sumabog ang ganitong produkto,” ang wika ni Domingo.

Paalala rin ng opisyal sa publiko na sundin ang mga direksyon sa pakete hinggil sa paggamit at pag-iimbak nito upang makaiwas sa aksidente. – RRD (mula sa ulat ni Correspondent Vincent Arboleda)

Phase 3 clinical trials for CoronaVac to possibly begin in November—FDA

Aileen Cerrudo   •   October 23, 2020

The Food and Drug Administration (FDA) said the phase 3 clinical trials for Sinovac’s CoronaVac would possibly begin in November, once the Chinese biopharmaceutical company submitted all the necessary documents.

The FDA said they are awaiting three documents from Sinovac to begin phase 3 of the clinical trial.

FDA Director-General Eric Domingo expressed confidence there will be a potential vaccine in the country by next month.

Ang aming timeline is mga two to three weeks. So once ma-complete naman nila ang submission at ma- kompleto nila lahat ng requirements ng FDA at ng Research Ethics Board, then maaari na silang magka-approval in the middle of November (Our timeline is around two to three weeks. So once they completed the submission and the requirements of the FDA and the Research Ethics Board, then there will be an approval by the middle of November), he said.

However, the agency clarified that CoronaVac could still not be administered to Filipinos.

The FDA assures that they will monitor the effect of the CoronaVac if it will be safe to use.

Hindi siya pwedeng dalhin dito at ibenta dito kasi hindi pa natin nakikita at hindi pa subok kung siya ay effective. Kaya hindi po tayo dapat mag- panic at biglang gumamit ng mga ito (It cannot be brought and sold here because we still cannot prove if it is effective. So we should not panic and use it), Domingo said. -AAC (with reports from Aiko Miguel)

COVID-19 vaccine approval in PH possible in April 2021 – FDA

Robie de Guzman   •   September 25, 2020

MANILA, Philippines – The country’s Food and Drug Administration (FDA) on Friday said the approval of a vaccine against novel coronavirus disease may be possible in April 2021.

During a virtual press briefing, FDA Director General Eric Domingo said this is “the best case scenario” if clinical trials are completed on schedule.

“If clinical trials are completed by December or January, and a company would file an application with FDA, it’s possible that by April 2021 we will have an approved vaccine,” he said.

“Talagang best case scenario yun, meaning yung three to six months, magiging three months; assuming that they will complete all their analysis and submitted immediately to FDA,” he added.

In the same briefing, Department of Science and Technology (DOST) Secretary Fortunato dela Peña said the time period of three to six months is the experts’ estimate on the completion of Phase III clinical trials for vaccine candidates.

“When they say 3-6 months, we prefer to use the longer forecast in our estimates. That would indicate in that period they would have finished clinical trials and probably already submitted to FDA their application and results of their trials,” he said.

Dela Peña said the World Health Organization (WHO) is set to release its list of selected vaccines and protocols in October and that the fastest that they can start the clinical trials will be in the last quarter of 2020.

“The vaccine trials according to experts will range from 3 to 6 months. I think the very early forecast that we have of second quarter 2021 is still the best forecast we can give,” he said.

The DOST said the Philippines is currently negotiating with 17 vaccine developers from other countries and six of them have already signed confidentiality disclosure agreements that would allow the sharing of their earlier trial results.

Among the six vaccine developers are Russia’s Gamaleya Research Institute and China’s Sinovac.

The FDA earlier promised it would expedite the approval procedures but assured that no steps will be skipped to ensure public’s health and safety. – RRD (with details from Correspondent Aiko Miguel)

FDA warns against purchase of unregistered food items including popular liver spread brand

Marje Pelayo   •   September 17, 2020

MANILA, Philippines — The Food and Drug Administration (FDA) on Wednesday (September 16) issued a warning against the purchase and consumption of several unregistered food and food supplements including a popular brand of liver spread.

According to its advisory dated August 26 and released only on September 16, the following products have no certificate of product registration issued and therefore unregistered in the agency:

  • Reno Brand Liver Spread
  • Miracle White Advance Whitening Capsules Food Supplement
  • Turcumin 100% Natural & Standardized Turmeric Curcumin
  • Desa Spanish Style Bangus In Corn Oil
  • Samantha’s Dips And Sauce Spanish Sardines Paste Sauce

“Since these unregistered food products and food supplements have not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety,” the advisory said.

The FDA cited the provision of the Food and Drug Administration Act of 2009, which states that “the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.”

The agency also warned establishments not to distribute, advertise or sell the said violative food products until a proper certificate of registration is issued.

Otherwise, they could face regulatory sanctions.

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