COVID-19 FDA UPDATES

DATE POSTED
TYPE OF ISSUANCE
TITLE
06 April 2020FDA AdvisoryFDA Advisory No. 2020-547 || Updated Procedure for FDA Clearance of Personal Protective Equipment (PPE) Prior to Customs Release
03 April 2020AnnouncementFDA approved 2 additional kits today (1 PCR, 1 RAPID), 03 April 2020. Total registered COVID-19 Test Kits for commercial use is now 30.
03 April 2020FDA AdvisoryFDA Advisory No. 2020-513 || FDA Approves the First Locally Manufactured Test Kit for COVID-19 for Commercial Use
03 April 2020Joint Memorandum CircularJoint Memorandum Circular No. 01 Series Of 2020 || CREATION OF BAYANIHAN ONE STOP SHOP FOR SECURING LICENSE TO OPERATE (LTO) TO IMPORT COVID-19 CRITICAL COMMODITIES FOR COMMERCIAL DISTRIBUTION
02 April 2020FDA CircularFDA Circular No. 2020-013 || Guidelines for Monitoring Drug Products Used for the Treatment of COVID-19
02 April 2020FDA CircularFDA Circular No. 2020-012 || Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)
02 April 2020FDA CircularFDA Circular No. 2020-006-A || AMENDMENT TO FDA CIRCULAR NO. 2020-006 ENTITLED “GUIDANCE FOR APPLICATIONS AND TRANSACTIONS AT THE FOOD AND DRUG ADMINISTRATION IN LIGHT OF THE COMMUNITY QUARANTINE DECLARATION” ISSUED ON 17 MARCH 2020
01 April 2020FDA AdvisoryFDA Advisory No. 2020-498 || PURCHASE AND ADMINISTRATION OF FDA APPROVED COVID-19 RAPID ANTIBODY TEST KITS
01 April 2020FDA AdvisoryFDA Advisory No. 2020-497 || DISTRIBUTION OF FDA APPROVED COVID-19 RAPID ANTIBODY TEST KITS
01 April 2020FDA AdvisoryFDA Advisory No. 2020-496 || Public Health Warning Against Do-It-Yourself Hand Sanitizers/Disinfectants
01 April 2020AnnouncementFDA approved 2 additional Rapid Antibody Test Kits today, 01 April 2020. Total registered COVID-19 Test Kits for commercial use is now 28.
31 March 2020AnnouncementFDA approved 3 additional kits today (2 PCR, 1 RAPID), 31 March 2020. Total registered COVID-19 Test Kits for commercial use is now 26.
30 March 2020Press StatementFDA APPROVES RAPID ANTIBODY TEST KITS FOR COVID-19
30 March 2020InfographicsRapid Diagnostic Test FAQs
30 March 2020FDA AdvisoryFDA Advisory No. 2020-483 || FDA APPROVES RAPID ANTIBODY TEST KITS FOR COVID-19
30 March 2020FDA AdvisoryFDA Advisory No. 2020-452 || Baseless Claims of “Prodex-B” as Anti-Viral Treatment for COVID-19
27 March 2020AnnouncementFDA approved 3 additional kits today, 27 March 2020. Total registered COVID-19 Test Kits for commercial use is now 18.
27 March 2020FDA AdvisoryFDA Advisory No. 2020-451-A || FDA EMAIL HOTLINE PARA SA MGA SUMBONG SA PRODUKTO NA MAY KINALAMAN SA COVID-19
27 March 2020FDA AdvisoryFDA Advisory No. 2020-451 || FDA EMAIL HOTLINE FOR COVID-19 RELATED REPORTS ON CONSUMER PRODUCTS
27 March 2020FDA AdvisoryFDA Advisory No. 2020-450 || Pharmacies to Dispense Hydroxychloroquine to Patients with Prescriptions for the Drug Use
27 March 2020FDA AdvisoryFDA Advisory No. 2020-449 || FDA Clearance of Ventilators, Respirators and Accessories Prior Customs Release
26 March 2020AnnouncementFDA approved 3 additional kits today, 26 March 2020. Total registered COVID-19 Test Kits for commercial use is now 15.
25 March 2020FDA CircularFDA Circular No. 2020-005-A || 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 Department Memorandum No. 2020-0058 and Department Memorandum No. 2020-0058-A
25 March 2020Press StatementUnregistered COVID-19 Test Kits
25 March 2020AnnouncementFDA approved 2 additional kits today, 25 March 2020. Total registered COVID-19 Test Kits for commercial use is now 12.
24 March 2020AnnouncementFDA approved 1 additional kit today, 24 March 2020. Total registered COVID-19 Test Kits for commercial use is now 10.
24 March 2020AnnouncementDapat bang uminom ng gamot tulad ng Hydroxychloroquine o Chloroquine para maiwasan ang COVID-19?
24 March 2020AnnouncementShould I take medicine like Hydroxychloroquine or Chloroquine to prevent COVID-19?
22 March 2020AnnouncementFDA approved 1 additional kit today, 23 March 2020. Total registered COVID-19 Test Kits for commercial use is now 9.
22 March 2020FDA AdvisoryWALA PANG APRUBADONG POINT-OF-CARE O INSTANT COVID 19 TEST KITS
21 March 2020FDA AdvisoryFDA Advisory No. 2020-434 || Public Health Advisory on the Purchase and Use of the Infared Thermometer for Medical Use Offered for Sale Online
20 March 2020AnnouncementFDA released 4 kits today, 20 March 2020. Total registered COVID-19 Test Kits for commercial use is now 8
20 March 2020AnnouncementThe FDA released two (2) more Approved COVID-19 Test Kits for Commercial Use today 20 March 2020.
20 March 2020FDA AdvisoryFDA Advisory No. 2020-422 || UPDATED LIST OF NOTIFIED HAND SANITIZERS AND REGISTERED TOPICAL ANTISEPTICS AND ANTIBACTERIALS
20 March 2020FDA AdvisoryFDA Advisory No. 2020-421 || HAND SANITIZER, ANTIBACTERIALS AND ANTISEPTIC SOLD THROUGH ONLINE STORES
20 March 2020FDA AdvisoryFDA Advisory No. 2020-420 || Procedure for FDA Clearance of Personal Protective Equipment (PPE) Prior Customs Release
19 March 2020Memorandum CircularFDA Memorandum Circular No. 2020-001 || 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
19 March 2020Press StatementList of FDA Approved Covid-19 Test Kits For Commercial Use
19 March 2020FDA AdvisoryFDA Advisory No. 2020-409 || List of Approved COVID-19 Test Kits for Commercial Use
19 March 2020FDA CircularFDA Circular No. 2020-009 || 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
18 March 2020FDA StatementPaglabas ng FDA Ng “Guidelines in the Implementation of the Use of Electronic Means of Prescription for Drugs for The Benefit of Individuals Vulnerable to Covid-19”
18 March 2020FDA Advisory FDA Advisory No. 2020-350 || List of Notified Hand Sanitizers
17 March 2020AnnouncementFDAC temporary location starting 17 March 2020
17 March 2020FDA CircularFDA Circular No. 2020-007 || Guidelines in the Implementation of the Use of Electronic Means of Prescription for Drugs for The Benefit of Individuals Vulnerable to COVID-19
16 March 2020FDA CircularFDA Circular No. 2020-006 || Guidance for Applications and Transactions at The Food and Drug Administration in Light of the Community Quarantine Declaration
15 March 2020FDA StatementFDA Clarifies Availability Of Covid-19 Test Kits In The Country
13 March 2020AnnouncementSubmission Hours of the Food and Drug Administration (FDA) Authorizations in The E-Portal System
12 March 2020FDA MemorandumFDA Memorandum No. 2020-006 || Issuance of Special Certification for Imported Test Kits of COVID-19
12 March 2020FDA CircularFDA Circular No. 2020-005 || 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
12 March 2020FDA CircularFDA Circular No. 2020-004 || Prohibition of Selling of COVID-19 Testing Kit without Authorization from FDA
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