FDA Protects Patients and Consumers from Fraud During COVID-19

Operation Quack Hack leverages agency expertise and advanced analytics to protect consumers from fraudulent medical products during the COVID-19 pandemic

  • As of June 2020, team has identified more than 700 fraudulent and unproven medical products 
  • Has reviewed thousands of websites, social media posts, and online marketplace listings
  • > 90 warning letters to sellers, more than 150 reports sent to online marketplaces, and more than 250 abuse complaints sent to domain registrars to date.

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First Tests to Estimate Patient’s IgG Antibodies from Past SARS-CoV-2 Infection

ADVIA Centaur COV2G and Atellica IM COV2G, Siemens

COVID-19 serology tests to estimate quantity of antibodies present in the individual’s blood

  • Useful tool to evaluate antibodies to a previous COVID-19 infection
  • Still many unknowns about what the presence of SARS-CoV-2 antibodies and potential immunity
  • Patients cautioned against using the results as an indication to stop taking steps to protect themselves and others
  • Instructions for Use

Advanced Manufacturing to Support Public Health Preparedness

Many medical products are still being manufactured using outdated technologies

  • Can increase the risk of shortages, limit flexibility during an emergency, and contribute to high cost
  • Encouraging “advanced manufacturing,” which refers to new and emerging approaches for production of medical technologies
  • Examples include process intensification methods, such as continuous manufacturing, 3D printing can help produce patient-specific medical devices, digital and smart design and manufacturing processes to increase efficiency and reduce uncertainty
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First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection

LabCorp COVID-19 RT-PCR Test EUA

For testing people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and to allow pooled sample testing 

  • Step toward the type of broad screening that may help enable the reopening of schools and workplaces
  • Also test pooled samples containing up to five individual swab specimens collected under observation
  • Help receiving results sooner, while also conserving vital testing supplies
  • Prescription-only and is authorized for human specimen collection either at home or by a health care provider
  • Only health care provider-collected samples may be pooled at this time
  • Test is as accurate in the broader asymptomatic population as it is among people suspected to have COVID-19
  • EUA Summary

If you have recovered from COVID-19, confirmed by a positive test, you’re in a special position to help us fight the virus. Donate plasma now


New Website on Cancer and COVID-19

FDA Oncology Center of Excellence recognizes cancer patients constitute a vulnerable population at risk ; current priorities

  • Expedite oncology product development
  • Recognize that modifications may be required in clinical trials
  • Innovating collection and analysis of real-world evidence on patient outcomes
  •  Process Expanded Access requests for investigational products
  • Anticipate and prevent drug shortages
  • Inform the cancer community

Cancer and COVID-19


Image credits: FDA, Labcorp, Siemens