FDA Memorandum No.2021-019 || Operation of Health Establishments/ Facilities in the Manufacture of Medical Gases without a License to Operate during the COVID-19 Pandemic
To address supply shortages brought about by the current COVID-19 pandemic, the Field Regulatory Operations Office (FROO) is directed to defer all regulatory enforcement action against health establishments/ facilities found […]
FDA Memorandum Circular No.2021-0001 || Extension of validity of License to Operate (LTO) and other market authorizations granted to Veterinary Establishments, Drugs, Biologicals and Products transferred from the Bureau of Animal Industry (BAI) to the Food nd Drug Administration (FDA)
Attachments FDA MEMORANDUM CIRCULAR 2021-001 (113 kB)
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 Memorandum No. 2020-022 || Performance Testing of Antigen Based Test Kits with Issued Special Certification
This is to inform all concerned that COVID-19 Antigen Based test kits with Special Certification shall likewise undergo performance validation by the Research Institute for Tropical Medicine (RITM) as a […]
FDA Memorandum No. 2020-011 || Performance Testing of Antibody Test kits with Issued Special Certification
All COVID-19 antibody test kits (rapid test, point-of-care, lateral flow, Elisa, GICA, CLIA, among others) with Special Certification shall undergo performance validation by the Research Institute for Tropical Medicine (RITM) […]
FDA Memorandum No. 2020-008 || Training Schedule for Supervising Pesticides Handlers
In the interest of ensuring public health and safety, the Food and Drug Administration (FDA), in coordination with the FDA Academy, the University of the Philippines —College of Public Health […]
FDA Memorandum No. 2020-006 || Issuance of Special Certification for Imported Test Kits of COVID-19
Pursuant to Section III. 6, Policies and Guidelines of FDA Circular No. 2018-0002, “Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements”, the […]