FDA permanently revokes Dengvaxia’s certificate of registration
admin • February 19, 2019 • 2405
The Food and Drug Administration has permanently revoked anti-dengue vaccine Dengvaxia’s certificates of product registration (CPR) due to the continued failure of manufacturer, Sanofi Pasteur Inc. to submit post-approval commitment documents.
FDA Director General Nela Charade Puno on Tuesday cited in a statement the French pharmaceutical firm’s disregard of the agency’s rules and regulations as reason for its CPRs’ cancellation.
“Its brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse but to impose the maximum penalty of revocation of the CPRs covering the Dengvaxia products,” Puno said.
The revocation of the Dengvaxia’s CPR makes its importation, sale and distribution illegal in the Philippines, according to the FDA.
Dengvaxia’s CPR was initially suspended for a year since December 29, 2017 after Sanofi’s failure to comply with post-marketing requirements.
Prior to the lapse of the one-year suspension on December 17, 2018, Sanofi failed to comply with post-marketing authorization requirements. The company has since then suspended the sale and marketing of the vaccine. — Robie de Guzman
MANILA, Philippines – Regulations on processed meat such as well-loved Filipino delicacies tocino and longganisa should be tightened by the Food and Drug Administration (FDA), according to the Department of Agriculture (DA).
According to Agriculture Undersecretary for Consumer Affairs Ernesto Gonzales, consumers cannot be complacent on buying these processed products especially if they are not sure of the source or origin of the raw meat.
Gonzales added that it is difficult to determine if the pork meat is contaminated with African Swine Fever (ASF) once it is processed.
He added that even ‘botcha’ or double-dead pork meat can be made into meat delicacies without the consumer noticing it because of colorings and extenders used in the process.
The official said the best way to determine if the pork meat is safe for consumption is to know the source of the raw meat, and if it is certified by the National Meat Inspection Service (NMIS).
“Kapag na-issue-han na ang karne from slaughterhouse ng meat inspection certificate (once meat from the slaughterhouse is issued with meat inspection certificate), definitely that meat is safe to eat,” Gonzales said.
However, the DA admitted that the government is lacking when it comes to regulations on processed meat so the coordination of the local government units (LGUs) is of utmost importance.
“Iyang problema natin yung mga maliliit na food processors na gumagawa ng mga longanisa, tocino, ang regulation hindi ganoon ka-strict ( The problem with small-time food processors or makers of longanisa and tocino is that the regulation is not that strict), ” Gonzales noted.
If ever the processed meat is infected with ASF, Gonzales said, it is still safe to eat, provided that it went through the proper cooking procedure of 30 minutes under 70’C temperature. – MNP (with details from Rey Pelayo)
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The FDA has warned establishments against selling these products.
“All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food products,” according to the FDA.
They also advised the public to always check if a food product or food supplement is registered with the FDA through their website (www.fda.gov.ph).—AAC
The Food and Drug Administration (FDA) has ordered Department of Health (DOH)-controlled hospitals to report cases that are related to using vape.
This was after health officials in the United Stated confirmed on Tuesday (September 10) that a 50-year-old man died of lung disease linked to vape use.
According to Dr. Anton Javier, project manager of Product Research and Standards Development Division Center for Cosmetics in the FDA, they might not monitor any illnesses related to using vape just yet because of the latency period.
“Because of the latency period nga po baka po wala pa tayo makita just yet. Pwede po kasing nagve-vape ka ngayon pero iyong mga magiging sakit niyo down the line pa, (Because of the latency period, we might not see [incidence] just yet. You can actually use vape now but your illness might appear down the line)” he said.
However, an expert said the confirmed case in the United States should not be a cause of alarm.
“It’s been well proven by laboratories in the US that deaths in Kansas whatever it is, has got nothing to do with e-cigarettes its what these people has put in e cigarettes that contains adulterated contaminants of cannabis,” according to Harm Reduction Expert Dr. Tikki Pang.
The FDA had previously released a regulation on using vape or e-cigarettes. Manufacturers or retailers were given until October 25 to register their products to the FDA.
The FDA has also warned against the dangers of the chemicals found in vape products. This include cynemaldehide which causes blockage in the lungs which can lead to difficulty in breathing.
Another dangerous chemical, according to the FDA, is diacetyl which causes bronchylitis or inflammation of the lungs.—AAC (with reports from Mai Bermudez)
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