FDA COVID News: Operation Quack Hack for fraud prevention, Test for IgG antibodies from previous infection, Test for screening prople without known infection, Advanced manufacturing for preparedness, Plasma donation, COVID and Cancer website
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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
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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Many medical products are still being manufactured using outdated technologies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
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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
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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
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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
Image credits: FDA, Labcorp, Siemens