FDA Circular No. 2021-008 || Updated Guidelines for the Registration of Drug Products under Emergency Use (DEU) for COVID-19
OBJECTIVE: This Circular aims to provide streamlined requirements and application process for the registration of Drug Products for COVID-19. Attachments FDA Circular No. 2021-008 (2 MB)
FDA Advisory No.2021-0759 || Clarification on the Approval and Use of Remdesivir
The Food and Drug Administration (FDA) clarifies that Remdesivir is not approved by the FDA for treatment of COVID-19. Remdesivir is use in adults and pediatric patients (12 years of […]
Clarification on the Approval and Use of Leronlimab
The Food and Drug Administration (FDA) clarifies that Leronlimab is not approved by the FDA for treatment of COVID-19. Leronlimab is an investigational product which is still undergoing clinical trials […]
FDA Advisory No.2021-0681 || Public Health Warning on Falsified COVID-19 Vaccine BNT162b2 Confirmed by the World Health Organization (WHO)
The Food and Drug Administration (FDA) notifies the public on the Medical Product Alert provided by the WHO, wherein a COVID-19 vaccine identified as “BNT162b2”, was detected in Mexico last […]
FDA has released a total of 410 COVID – 19 Test Kits (133 – PCR based, 115 – Rapid Antibody, 73 – Immunoassay and 89 – Others
As of 08 April 2021, FDA has released a total of 410 COVID – 19 Test Kits (133 – PCR based, 115 – Rapid Antibody, 73 – Immunoassay and 89– […]
FDA Advisory No. 2021-0664 || Public Health Warning on Fake COVID-19 Vaccines
As the COVID-19 pandemic continues to affect the world and with the global rush in the development and distribution of vaccines, criminal groups and unscrupulous enterprising people have also been […]
FDA Press Statement || Clarification on the purchase and use of Ivermectin 29 March 2021
Following issues on the use or prohibition of use of Ivermectin, the Food and Drug Administration (FDA) clarifies that there is no ban on the purchase and use of the […]
FDA has released a total of 408 COVID – 19 Test Kits (133 – PCR based, 115 – Rapid Antibody, 73 – Immunoassay and 87 – Others
As of 26 March 2021, FDA has released a total of 408 COVID – 19 Test Kits (133 – PCR based, 115 – Rapid Antibody, 73 – Immunoassay and 87 […]
FDA Memorandum No. 2021-009 || Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection
I. RATIONALE On 12 March 2020, Food and Drug Administration (FDA) Memorandum No. 2020-006 was approved allowing for the issuance of Special Certification for imported in-vitro diagnostic […]
FDA has released a total of 366 COVID – 19 Test Kits (126 – PCR based, 105 – Rapid Antibody, 68 – Immunoassay and 67 – Others).
As of 29 January 2021, FDA has released a total of 366 COVID – 19 Test Kits (126 – PCR based, 105 – Rapid Antibody, 68 – Immunoassay and 67 […]