Drug & Device Advisory Group FDA Briefs

COVID-19 Updates: At-a-glance resource, Caution on Hydroxychloroquine or Chloroquine use, Remote digital pathology devices

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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

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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

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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

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Drug & Device Advisory Group FDA Briefs

COVID-19 Updates

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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

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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

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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

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COVID-19 Diagnostics Update

 

Drug & Device Advisory Group Link and Learn

Coronavirus pandemic and making a difference

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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 

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Drug & Device Advisory Group FDA Briefs

FDA COVID-19 actions

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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

Drug & Device Advisory Group FDA Briefs

Coronavirus Treatment Acceleration Program (CTAP)

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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

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Drug & Device Advisory Group Link and Learn

FDA COVID-19 Updates

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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

Or search

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Includes links to CDC, OSHA and USA.gov

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