COVID-19 Updates: At-a-glance resource, Caution on Hydroxychloroquine or Chloroquine use, Remote digital pathology devices
FDA COVID-19 RESPONSE: At-a-Glance Summary
Major focus areas
- Testing, therapeutics, and devices such as ventilators and personal protective equipment
- Vaccine development
- Food supply
- Action on fraudulent products
Cautions against use of hydroxychloroquine or chloroquine for COVID-19 due to risk of heart rhythm problems
- Reports of serious and potentially life-threatening heart rhythm problems
- May be mitigated when health care professionals closely screen and supervise COVID-19 patients in a hospital setting or a clinical trial
Remote Digital Pathology Devices During COVID-19 Emergency
Guidance to help expand the availability of digital pathology devices for remote reviewing and reporting of scanned digital images of pathology slides during this pandemic
- Automated Digital Image Manual Interpretation Microscope
- Whole Slide Imaging System
- Digital Pathology Image Viewing and Management Software
- Digital Pathology Display
Expanded, off-label use for the duration of the COVID-19 public health emergency
- Facilitate remote reviewing and reporting of pathology slides
- Help facilitate continuity of patient care
- Reduce healthcare personnel contact and risk of exposure
Image credit: FDA
COVID-19 Updates
ACTIV Public-private partnership to speed COVID-19 vaccine and treatment options
NIH announced ‘Accelerating COVID-19 Therapeutic Interventions and Vaccines’ (ACTIV) partnership with FDA and others to speed the development of COVID-19 vaccine and treatment options
- Standardize and share preclinical evaluation methods in open forum allowing for comparison and validation
- Prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential
- Maximize clinical trial capacity and effectiveness
- Advance vaccine development
Protecting Public Health from Fraudulent and Potentially Harmful Products
Temporary injunction against the Genesis II Church of Health and Healing (Genesis)
- Unlawfully distributing MMS: When combined with included activator, has a chlorine dioxide content equivalent to industrial bleach
- There is danger that defendants will continue violating the law without temporary restraining order; defied previous Warning letter
Warning letter to Nova Botanix LTD DBA CanaBD
- Selling unapproved and misbranded cannabidiol (CBD) product deliberately misleading claims for prevention and treatment of COVID-19
- Currently NO FDA-approved products to prevent or treat COVID-19
Expansion of COVID-19 Testing by Using Synthetic Swabs
FDA, Gates Foundation, UnitedHealth Group, Quantigen, U.S. Cotton Collaborate to Address Testing Supply Needs
Synthetic swabs – with a design similar to Q-tips – could be used to test patients by collecting a sample from the front of the nose
U.S. Cotton
- Developed polyester-based, synthetic Q-tip-type swab for compatibility with COVID-19 testing
- Plans to produce the new swabs in large quantities for increased diagnostic testing
UnitedHealth Group, Quantigen, Gates Foundation
- Clinical investigation to support synthetic swab use
- Testing to support swabbing at front of nose used enabling more comfortable, self-collection by patients and limiting exposure of healthcare providers
Emergency Use Authorization (EUA): Seraph 100 Microbind Affinity Blood Filter device
INDICATION FOR USE: Extracorporeal blood purification (EBP) device) to treat patients 18 years of age or older with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure to reduce pathogens and inflammatory mediators from the bloodstream
- Designed to reduce bacteria, viruses, toxins, cytokines and other inflammatory mediators from whole blood
- Form factor very similar to other blood filters, such as hemodialyzers or hemoperfusion filters – compatible with hemodialysis systems that use industry standard bloodline connectors for ease of operation, training, and utility
COVID-19 Diagnostics Update
- 320 test developers planning to submit EUA
- 39 individual emergency use authorizations for test kit manufacturers and laboratories
- >190 laboratories testing under COVID-19 Policy for Diagnostic Tests
- Updated COVID-19 Diagnostics FAQ
Coronavirus pandemic and making a difference
Make a Difference During the Coronavirus Pandemic
FDA suggested ways for you and your family to make a difference
- Protect Yourself and Others
- Donate Blood
- Donate Plasma if fully recovered from COVID-19
- Report fraudulent Tests, Vaccines, and Treatments
- Save Personal Protective Equipment for those on the front lines
- Reduce Food panic-buying
- Clean Hands often
More information
Image credit: FDA
FDA COVID-19 actions
FDA COVID-19 updates
The Agency is playing an integral role in the coronavirus fight, using science and innovative approaches as well as joining in the healthcare frontlines
Here are some of the recent actions
- COVID-19 Q&As
- FAQs on Shortages of Surgical Masks and Gowns (Updated)
- FAQs on Diagnostic Testing for SARS-CoV-2 (Updated)
- Updated Emergency Use Authorizations
- Serological Tests
- Blood-related Therapies
- Generic approval of Albuterol Inhaler to Treat and Prevent Bronchospasm
- Food Safety
- FDA and FTC Warning Letters . Warning to Genesis 2 church
Image credit: FDA
Coronavirus Treatment Acceleration Program (CTAP)
Coronavirus Treatment Acceleration Program (CTAP)
Special emergency program for possible therapies – to be updated real time
Therapeutics
- 10 therapeutic agents in active trials
- Another 15 therapeutic agents in planning stages
Actions
- Rapid responses to queries, ultra-rapid review of protocol, development plans
- Review single patient expanded access requests within 3 hours
FDA COVID-19 Updates
Coronavirus Disease 2019 (COVID-19)
FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak
Read about
- Latest COVID-19 Information From the FDA
- Frequently Asked Questions
- Medical Countermeasures
- How to Help
- Report a Problem
- Health Fraud
- Contact FDA
- Additional Resources
Or search
Includes links to CDC, OSHA and USA.gov
Image credit: FDA