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COVID-19 Testing and Supplies Resources

 

Date Published Source Title/Link/Description
8/10/20 HHS COVID-19 State Testing Plans (July-December)
8/8/20 CDC
8/5/20 FDA
8/1/20 CDC
7/30/20 FDA
7/29/20 HHS
7/23/20 FDA
7/17/20 CDC
7/17/20 CDC
7/17/20 CDC
7/10/20 HHS
7/7/20 HHS
7/6/20 FDA
7/6/20 CDC
7/4/20 CDC
7/3/20 CDC
7/2/20 CDC
7/2/20 FDA
6/27/20 CDC
6/16/20 FDA
6/12/20 CDC
6/12/20 FDA
6/7/20 FDA
6/4/20 HHS
6/4/20 HHS
5/27/20 FDA
5/24/20 CDC
5/17/20 CDC
5/17/20 CDC
5/17/20 CDC
5/16/20
FDA Coronavirus (COVID-19) Update: FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests
5/12/20
CMS Price Transparency: Requirements for Providers to Make Public Cash Prices for COVID-19 Diagnostic Testing
5/11/20 White House White House Fact Sheet on Testing
5/11/20 CDC
5/11/20 FDA FAQs on Testing for SARS-CoV-2 – Updated
5/8/20 CMS Medicare Pharmacies and Other Suppliers May Temporarily Enroll as Independent Clinical Diagnostic Laboratories 
5/4/20 FDA Policy for Coronavirus Disease-2019 tests During the Public Health Emergency (Revised)
5/1/20 FDA Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment
5/1/20 FDA Fact Sheet for Patients and Parent/Caregivers: Emergency Use Authorization (EUA) of Remdesivir for Coronavirus Disease 2019 (COVID-19)
5/1/20 FDA Fact Sheet For Health Care Providers: Emergency Use Authorization (EUA) of Remdesivir
4/30/20 CMS Interim Final Rule: Medicare and Medicare, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
4/30/20 CMS Updated COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers
4/27/20 CDC
4/20/20 CDC
4/14/20 CDC
4/14/20 CMS
4/12/20 FDA Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Decontaminate Millions of N95 Respirators
4/11/20 CMS Trump Administration Announces Expanded Coverage for Essential Diagnostic Services Amid COVID-19 Public Health Emergency
4/8/20 FEMA FEMA COVID-19 Supply Chain Task Force: Supply Chain Stabilization
4/8/20 FDA FAQs on Shortages of Surgical Masks and Gowns
4/8/20 OSHA
4/7/20 FEMA
4/3/20 RWJF COVID-19 Scenario Generation Tool
4/1/20 CDC
3/31/20 White House Delegation of Certain Functions and Authorities under the National Defense Authorization Act for Fiscal Year 2020
3/31/20 FDA Current Shortages of Hydroxychloroquine and Chloroquine
3/31/20 FDA Warning Letter: Bioactive C60/FullerLifeC60 LLC
3/31/20 FDA Warning Letter: Halosense Inc.
3/31/20 FDA Coronavirus Treatment Acceleration Program (CTAP)
3/31/20 FDA Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19
3/31/20 HHS Optimizing Ventilator Use during the COVID-19 Pandemic
3/30/20 FDA FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation
3/30/20 HHS HHS Accelerates Clinical Trials, Prepares for Manufacturing of COVID-19 Vaccines
3/30/20 FDA Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency
3/30/20 FDA FDA Updates COVID-19 EUA Information for the QIAstat-Dx Respiratory SARS-CoV-2 Panel
3/30/20 FDA FDA Updates COVID-19 EUA Information for NeuMoDx SARS-CoV-2 Assay from NeuMoDx Molecular, Inc.
3/30/20 FDA Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19
3/30/20 FDA JRB Enterprise Group Inc. DBA Anti Aging Bed
3/30/20 HHS Secretary Azar Statement on FDA Authorization of Mask Sterilization Procedure
3/29/20 White House Remarks by President Trump in a Meeting with Supply Chain Distributors on COVID-19
3/29/20 HHS HHS accepts donations of medicine to Strategic National Stockpile as possible treatments of COVID-19 patients
3/28/20 FDA Coronavirus (COVID-19) Update: FDA Takes further steps to help mitigate supply interruptions of food and medical products
3/27/20 FDA Notifying FDA of a Permanent Discontinuance of Interruptions in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry
3/27/20 FDA Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients
3/27/20 FDA FDA Updates COVID-19 EUA Information for NcTAG CoV Extended Panel Assay from Luminex Molecular Diagnostics
3/27/20 FDA FDA Updates COVID-19 EUA Information for ID NOW COVID-19 from Abbott Diagnostics
3/27/20 DEA Exception to Regulations Emergency Oral CII Prescription
3/26/20 CMS Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency
3/26/20 FDA FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
3/26/20 FDA FAQs on Diagnostic Testing for SARS-CoV-2 – UPDATED
3/26/20 FDA FDA Updates COVID-19 EUA Information for Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV
3/25/20 FDA Enforcment Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
3/25/20 FDA Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
3/25/20 DEA DEA State Reciprocity
3/25/20 FDA FDA Updates COVID-19 EUA Information for AvellinoCoV2 Test
3/24/20 FDA Coronavirus (COVID-19) Update: FDA Takes action to increase U.S. supplies through instructions for PPE and device manufacturers
3/24/20 FDA Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
3/24/20 FDA FDA Updates COVID-19 EUA Information for PerkinElmer New Coronavirus Nucleic Acid Detection Kit
3/24/20 HHS Emergency Use Authorization Declaration
3/24/20 CMS FAQs on Prescription Drugs and the Coronavirus Disease 2019 (COVID-19) for Issuers Offering Health Insurance Coverage in the Individual and Small Group Markets
3/24/20 FDA Temporary Policy for Manufacturer of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry
3/24/20 FDA Investigational COVID-19 Convalescent Plasma – Emergency INDs
3/23/20 OIG A Message from HHS OIG Leadership on COVID-19 Fraud
3/23/20 FDA FDA Updates COVID-19 EUA Information for Mesa Biotech Inc. Diagnostic Test
3/23/20 FDA FDA Updates COVID-19 EUA Information for BioFire Defense, LLC Diagnostic Test
3/23/20 FDA FAQs on Diagnostic Testing for SARS-CoV-2
3/21/20 FDA Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic
3/20/20 FDA Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
3/20/20 DEA DEA’s response to COVID-19: DEA is protecting the nation’s prescription drug supply chain
3/20/20 FDA Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits
3/18/20 HHS HHS Supports Mesa Biotech to Develop a Rapid Diagnostic to Detect Novel Coronavirus Infections
3/16/20 FDA Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics
3/16/20 FDA Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp
3/13/20 FDA Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic
3/13/20 FDA Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Thermo Fisher
3/13/20 CMS Medicare Administrative Contractor (MAC) COVID-19 Test Pricing (PDF) 
3/12/20 FDA Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic 
3/7/20 FDA Coronavirus (COVID-19) Update: White House Press Briefing by FDA Commissioner Stephen M. Hahn, M.D.
3/5/20 CMS CMS Develops Additional Code for Coronavirus Lab Tests 
3/1/20 Lee Health Provider Testing Algorithm
2/29/20 FDA Emergency Use Authorization to two public health laboratories in New York
2/29/20 FDA Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics
2/13/20 CMS Public Health News Alert: CMS Develops New Code for Coronavirus Lab Test
2/6/20 CMS Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for Authorized Laboratories 
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