FDA Advisory No.2022-0064 || Reiteration of FDA Advisory No. 2021-3195 and FDA Advisory No. 2021-3523 entitled Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “CLUNGENE RAPID TEST COVID-19 ANTIGEN RAPID TEST CASSETTE”
The Food and Drug Administration (FDA) reiterates its advisory to all healthcare professionals and the general public NOT TO PURCHASE AND USE the uncertified COVID-19 test kit “Clungene Rapid Test […]
FDA Advisory No.2022-0053 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “ARIA COVID-19 AG 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: ARIA COVID-19 AG TEST The FDA […]
FDA Advisory No.2022-0052 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “HEALGEN® CORONAVIRUS AG RAPID TEST CASSETTE (SWAB)”
The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE this uncertified COVID-19 test kit: HEALGEN® CORONAVIRUS AG RAPID TEST CASSETTE […]
FDA Advisory No.2021-3527-A || Lifting of the FDA Advisory No. 2021-3527 entitled Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kits: ICHROMA COVID-19 AG
The Food and Drug Administration (FDA) informs the public that Ichroma COVID-19 Ag, with Registration No. SC-2022-001, has been registered by the Market Authorization Holder (MAH), VITALINE HEALTHCARE INC., in […]
FDA Advisory No.2022-0025 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “ECOTEST COVID-19 ANTIGEN NASAL TEST 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. ECOTEST COVID-19 ANTIGEN NASAL TEST […]
FDA Circular No.2021-011-A || Extension of Transitory Period and Provision of Interim Guidelines for Product Registration, including the Labeling Requirements, for Household Urban/Hazardous Substances
I. RATIONALE On 24 May 2021, the Food and Drug Administration (FDA) issued FDA Circular No. 2021-011 with subject, Extension of Transitory Period for the Implementation of FDA Circular No. […]
FDA Advisory No.2022-0001-A || Amendment to FDA Advisory No. 2022-0001 Entitled “Food and Drug Action Center (FDAC) Services Beginning 10 January 2022”
In its commitment to provide effective and efficient releasing of authorizations to its clients, the Food and Drug Administration will re-open its Releasing Unit at the FDA main office located […]
FDA Advisory No.2022-0024 || Applications for Compassionate Special Permit (CSP) of Covid-19 Drugs
The Food and Drug Administration (FDA) received reports of limited access to COVID-19 Drugs granted with Emergency Use Authorization (EUA) such as Molnupiravir and Casirivimab + Imdemivab due to the […]
FDA Press Statement || FDA APPROVES SELF-ADMINISTERED COVID-19 ANTIGEN TEST KITS
The Food and Drug Administration (FDA) has approved two (2) self-administered COVID-19 antigen test kits in compliance with the application requirements listed in the FDA Advisory No. 2021-0684 entitled “Guidance […]
FDA Advisory No.2022-0022 || Reiteration on the Distribution and Purchase of FDA Certified COVID-19 Test Kits (RT-PCR, Antibody, and Antigen based)
In the interest of service, the Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the Covid-19 Test Kits from Unauthorized […]