Circular No. 2020-016 | May 11, 2020 | Prohibition of Online Selling of FDA Certified COVID- 19 Antibody Test kits | View |
Advisory No. 2020-782 | May 8, 2020 | Public Health Warning Against the Unapproved and Misleading Health Claims of Medical Devices that Decrease the Risk of Coronavirus Disease (COVID-19) Infection | View |
Circular No. 2020-009-B | April 29, 2020 | Amendment to Include Respiratory Therapy Devices in the List of Medical Devices Covered ny FDA Circular No.2020-009, as Amended by FDA Circular No. 2020-009-A | View |
Advisory No. 2020-761 | April 29, 2020 | FDA Clearance of Respiratory Therapy Devices Prior Customs Release | View |
Advisory | April 24, 2020 | FDAC Additional Hotlines | View |
Advisory No. 2020-744 | April 22, 2020 | Advisory for the Issuance of Special Permit for Medical Radiation Facilities Using Loaned Mobile X-ray Devices during the COVID-19 Pandemic | View |
Circular No. 2020-015 | April 21, 2020 | Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic | View |
Memorandum 2020-011 | April 20, 2020 | Performance Testing of Antibody Test Kits with Issued Special Certification | View |
Advisory No. 2020-671 | April 18, 2020 | Varying Specifications and Use of COVID-19 Rapid Antibody Test Kits | View |
Memorandum Circular No. 2020-001-A | April 16, 2020 | Amendment to FDA Memorandum Circular No. 2020-001 entitled Interim Guidelines for the Issuance of Provisional License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers of Rubbing Alcohol Products under the Center for Cosmetics Regulation and Research | View |
Press Statement | April 8, 2020 | FDA Warns the Public on Drugs and Vaccines with Unproven Claims for COVID-19 Treatment | View |
Circular No. 2020-014 | April 8, 2020 | Interim Guidelines on the Manufacture of Personal Protective Equipment (PPE), Ventilators, and Respirators in Light of COVID-19 Situation | View |
Advisory No. 2020-531 | April 3, 2020 | Public Health Warning Agaist the Unapproved and Misleading Advertisement of Food Products and Food Supplements Claiming to Boost Immune System and Decrease the Risk for Coronavirus Disease (COVID)-19 Infection | View |
Advisory No. 2020-496 | March 30, 2020 | Public Health Warning Against Do-It-Yourself Hand Sanitizers/Disinfectants | View |
Advisory No. 2020-483 | March 30, 2020 | List of Approved COVID-19 Rapid Antibody Test Kits | View |
Advisory No. 2020-452 | March 30, 2020 | Baseless Claims of “Prodex-B” as Anti-Viral Treatment for COVID-19 | View |
Advisory No. 2020-451 | March 27, 2020 | FDA Email Hotline for COVID-19 Related Reports on Consumer Products | View |
Advisory No. 2020-450 | March 27, 2020 | Pharmacies to Dispense Hydroxychloroquine to Patients with Prescriptions for the Drug Use | View |
Advisory No. 2020-449 | March 23, 2020 | FDA Clearance of Ventilators, Respirators and Accessories Prior Customs Release | View |
Advisory No. 2020-434 | March 20, 2020 | Public Health Advisory on the Purchase and Use of the Infrared Thermometer for Medical Use Offered for Sale Online | View |
Circular No. 2020-005-A | March 20, 2020 | Amendment to FDA Circular No. 2020-005 Re: Prohibition on the Online Selling of Essential Emergency Medical Supplies Beyond the Price Ceiling/Range Set by the Department Memorandum No. 2020-0058 and Department Memorandum No. 2020-0058-A | View |
Advisory No. 2020-421 | March 20, 2020 | Hand Sanitizer, Antibacterials and Antiseptic Sold Through Online Stores | View |
Advisory No. 2020-422 | March 20, 2020 | Updated List of Notified Hand Sanitizers and Registered Topical Antiseptics and Antibacterials | View |
Circular No. 2020-009 | March 19, 2020 | Guidelines on the Identification, Notification, Evaluation, Regulatory Enforcement Action, and Review and Monitoring of Donated Health Products Solely Intended to Address COVID-19 Public Health Emergency | View |
Memorandum Circular No. 2020-001 | March 19, 2020 | Interim Guidelines for the Issuance of Provisional Licence to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers of Rubbing Alcohol Products Under the Center for Cosmetics Regulation and Research | View |
Advisory No. 2020-409 | March 19, 2020 | List of Approved COVID-19 Test Kits for Commercial Use | View |
Circular No. 2020-007 | March 17, 2020 | Guidelines in the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19 | View |
Circular No. 2020-006 | March 17, 2020 | Guidance for Applications and Transactions at the Food and Drug Administration in Light of the Community Quarantine Declaration | View |
Advisory No. 2020-350 | March 16, 2020 | List of Notified Hand Sanitizers | View |
Advisory No. 2020-349 | March 13, 2020 | Conduct of Foreign Inspections | View |
Circular No. 2020-005 | March 12, 2020 | Prohibition on the Online Selling of Essential Emergency Medical Supplies Beyond the Price Ceiling/Range set by Department Memorandum No. 2020-0058 and Department Memorandum No. 2020-0058-A | View |
Circular No. 2020-004 | March 12, 2020 | Prohibition of Selling of COVID-19 Testing Kit without Authorization from FDA | View |
Press Release | March 9, 2020 | FDA Allows Use of COVID 19 Test Kits Developed by Local Scientists | View |