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.


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Many medical products are still being manufactured using outdated technologies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
  • READ

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