FDA Advisory No.2022-0017 || Public Health Warning Against the Purchase and Use of the Uncertified Self-Administered COVID-19 Test Kit “ARIA SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)”
The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the uncertified self-administered COVID-19 test kit: ARIA SARS-CoV-2 Antigen Rapid Test […]
FDA Advisory No.2022-0005 || Public Health Warning Against the Alleged Rampant Selling of Molnupiravir in the Market
The Food and Drug Administration (FDA) warns all healthcare professionals and the public on significant risks associated with the growing sales of the drug product Molnupiravir in the market. The […]
FDA Advisory No.2022-0006 || UPDATED LIST OF DRUG PRODUCTS UNDER EMERGENCY USE (DEU) FOR COVID-19
Under FDA Circular 2021-008 or the Updated Guidelines for the Registration of Drug Products Under Emergency Use (DEU) for COVID-19, licensed drug establishments intending to manufacture and import/ distribute drug […]
FDA Advisory No.2022-0003 || New Office Address and Contact Numbers of the Food and Drug Action Center (FDAC)
Due to the recent fire incident in Starmall Alabang, the Food and Drug Action Center will temporarily be transferred and serve its clients in FDA Main Office. Please note of […]
FDA Circular No.2020-037-B || Extension of the Effectivity of FDA Circular No. 2020-037 Entitled “Reissuance of the Guidelines on the Implementation of the use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to Covid-19”
In the interest of service and due to the continuing COVID-19 Pandemic, the effectivity of FDA Circular No. 2020-037 entitled “Reissuance of the Guidelines on the Implementation of the Use […]
FDA Circular No.2020-018-A || Extension of the Effectivity of FDA Circular No. 2021-018 Entitled “Updated Guidelines on the Identification, Notification, Evaluation, Regulatory Enforcement Action, and Review And Monitoring of Donated Health Products Solely Intended to Address the Covid-19 Public Health Emergency”
In the interest of service and due to the continuing COVID-19 Pandemic, the effectivity of FDA Circular No. 2021-018 entitled “Updated Guidelines on the Identification, Notification, Evaluation, Regulatory Enforcement Action, […]
FDA Circular No.2021-018-A || Extension of the Effectivity of FDA Circular No. 2021-018 Entitled “Updated Guidelines on the Identification, Notification, Evaluation, Regulatory Enforcement Action, and Review and Monitoring of Donated Health Products Solely Intended to Address the Covid-19 Public Health Emergency”
In the interest of service and due to the continuing COVID-19 Pandemic, the effectivity of FDA Circular No. 2021-018 entitled “Updated Guidelines on the Identification, Notification, Evaluation, Regulatory Enforcement Action, […]
FDA Advisory No.2021-2452-A || Lifting the Advisory of NADAL COVID-19 Ag Test under FDA Advisory No. 2021-2452 entitled: Caution on the purchase and use of certain COVID-19 Test Kits following the performance validation conducted by the RITM
The Food and Drug Administration (FDA) informs all healthcare professionals and general public that the advisory on NADAL COVID-19 Ag Test manufactured by Nal Von Minden GmbH under FDA Advisory […]
FDA Advisory No.2021-3604-A || Amendment to FDA Advisory No. 2021-3604 Entitled “Acceptance of Application for Special Certification for COVID-19 Self-Test Kits”
The Food and Drug Administration hereby informs all concerned stakeholders that FDA Advisory No. 2021-3604 entitled “Acceptance of Application for Special Certification for COVID-19 Self-Test Kits” is amended to change […]
FDA Advisory No.2021-3604 || Acceptance of Application for Special Certification for COVID-19 Self-Test Kits
In the interest of service, the Food and Drug Administration hereby informs all concerned stakeholders that the FDA shall start the acceptance of applications for Special Certification of COVID-19 self-test […]