FDA Press Statement || FDA Philippines Grants Emergency Use Authorization of CoronaVac (Sinovac) for Pediatric Group
On 11 March 2022, the Food and Drug Administration (FDA) granted the Emergency Use Authorization (EUA) of CoronaVac Vaccine, manufactured by Sinovac Life Sciences, for the prevention of COVID-19 in […]
FDA Circular No.2021-015-A || Extension of FDA Circular No. 2021-015 entitled “Interim Guidelines on the Renewal of Current Good Manufacturing Practice (cGMP) Clearance of Foreign Drug Manufacturers”
In the interest of service and due to the continuing COVID-19 Pandemic, the effectivity of FDA Circular (FC) No. 2021-015 entitled “Interim Guidelines on the Renewal of Current Good Manufacturing […]
FDA Advisory No.2022-0415 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “GENEFINDER® COVID-19 AG SELF-TEST”
The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the uncertified COVID-19 test kit: 1. GENEFINDER® COVID-19 AG SELF-TEST The […]
FDA Advisory No.2022-0409 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “NANOCARE™ COVID-19 ANTIGEN (AG) KIT”
The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the uncertified COVID-19 test kit: 1. NANOCARE™ COVID-19 ANTIGEN (AG) KIT […]
FDA Advisory No.2022-0383 || Reiterating the Article 8 of the ASEAN Cosmetic Directive as per FDA Circular No. 2018-001 Mandating the “Product Information File”
The ASEAN Cosmetic Directive (ACD) aims to primarily ensure the safety, quality, and claimed benefits of cosmetic products among ASEAN Member States (AMS). Secondly, the ACD aims to reduce technical […]
Draft for Comments || Guidelines on the Issuance of License to Operate for Drug Establishments Engaged in E-Pharmacy
All comments can be sent at [email protected]. Deadline of submission of comments shall be by 28 March 2022. I. BACKGROUND/RATIONALE The World Trade Organization defines Electronic commerce (E-commerce) as the […]
FDA Advisory No.2022-0136 || List of VAT-Exempt Health Products pursuant to Republic Act No. 11534, otherwise known as the “Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act” and Frequently Asked Questions (FAQs)
For the information of all concerned, the List of Medicines for Hypertension, Cancer, Mental Illnesses, Tuberculosis, Kidney Diseases, Diabetes, and High Cholesterol, pursuant to the Implementing Guidelines on the Value-Added […]
FDA Advisory No.2022-0066 || Public Health Warning Against the Purchase and Use of the following Medical Device Products with Expired Certificate of Product Registration:
The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the medical device products with expired Certificate of Product Registration: 1. […]
Announcement || NOTICE OF VIRTUAL PUBLIC HEARING
As part of the mandate of the Food and Drug Administration (FDA) to protect public health and safety through regulation of health products including in vitro diagnostic medical devices (IVDs) […]
FDA Advisory No.2022-0107 || Reiteration on Prohibition of Online Selling of FDA Certified COVID-19 Test Kits including Self Administered COVID-19 Test Kits
By virtue of Republic Act No. 9711, otherwise known as the “Food and Drug Administration (FDA) Act of 2009”, the FDA is mandated to protect the health and safety of […]