FDA Terminology of COVID-19 Potential Preventions and Treatments

  • FDA Approved: Independent scientific reviews to determine safety and effectiveness for its intended use and manufactured according to federal quality standards
  • Investigational Treatment:  Experimental- to study use in diease/condition, safety, dose, benefits and risks
  • Expanded Access: Potential pathway for patient with serious/immediately life threatening disease to gain access to investigational product outside of clinical trials
  • Emergency Use Authorization (EUA): Different than approval or clearance; product availability based on the best available evidence, without waiting for all the evidence. Effective until emergency declaration ends
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First Standalone At-Home Sample Collection Kit 

Everlywell COVID-19 Test Home Collection Kit

INDICATION: For use by individuals to self-collect nasal swab specimens at home, when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire, and for use only with in vitro diagnostic (IVD) molecular tests for the detection of
SARS-CoV-2 RNA that are indicated for use with the Everlywell COVID-19 Home Collection Kit

DESCRIPTION:

  • Used by individuals at home screened via online questionnaire & reviewed by health care provider
  • Self-collect a nasal sample at home using Everlywell’s authorized kit (nasal swabs and tube filled with saline to transport the sample back to a specified lab)
  • Samples tested by specific CLIA-certified laboratories each with individual EUAs to test Everlywell at-home sample collection kit (Fulgent Therapeutics, Assurance Scientific Laboratories)
  • Results to patient through Everlywell’s independent physician network and online portal

SUPPORTING DATA:

  • Data from studies supported by The Bill and Melinda Gates Foundation and UnitedHealth Group to demonstrate stability of specimens during shipping
  • Study data freely available to support other EUA requests, alleviating burden of recreating the same study 

EUA


COVID MyStudies App

  • Free platform to remotely obtain informed consent from patients in COVID-19 trials
  • To assist with clinical trials when patients are in or unable to outpatient clinics
  • In Apple App and Google Play

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Guidance on Steps to Streamline Development of Tests

  • Steps to further support development of COVID-19 tests for at-home self-collection
  • Voluntary  EUA Template for at-home sample collection kits
  • Template reflects FDA’s current thinking on data and information that developers should submit to facilitate EUA process
  • Includes recommendations for use by laboratories and commercial manufacturers
  • Applies to EUA as well as part of an Institutional Review Board (IRB)-approved study

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Cancer Doctor’s Perspective: Hydroxychloroquine and Chloroquine

FDA plays pivotal role to provide new medical products to patients as soon as possible, while at the same time determining effectiveness and if benefits outweigh the risks

Drugs hydroxychloroquine and chloroquine have received particular attention

  • Both are FDA-approved to treat or prevent malaria, and hydroxychloroquine is also approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis – have a well-established safety profile for these conditions
  • NOT approved to prevent or treat COVID-19 – subject of numerous clinical trials
  • FDA neither endorses individual prescribing decisions nor prohibits physicians from prescribing
  • It is important that patients and health care providers understand side effects including serious and potentially life-threatening heart rhythm problems as noted in a recent Drug Safety Communication
  • FDA issued EUA that allowed for treatment of certain hospitalized COVID-19 patients for whom a clinical trial is not available, or participation is not feasible
  • Will continue to look at the data to make future determinations on these products based on available evidence including ongoing clinical studies

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Updated page on current and terminated Emergency Use Authorizations for COVID-19


Image credit: FDA