COVID-19 updates: Facilitating development and availability of medical products, New actions to accelerate development of novel treatment options, Surveillance inspections

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Facilitating development and availability of medical devices

Working to facilitate development and availability of medical products for patients, physicians, healthcare systems as expeditiously and safely as possible

  • Emergency Use Authorizations (EUAs): Quickly allowing unapproved medical products to reach patients in need when there are no adequate, FDA-approved alternatives
  • Deal with supply issues
  • Updated website

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Facilitating development and availability of drugs 

Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of potential COVID-19 therapies

  • Several therapies currently being tested in clinical trials to evaluate whether
    they are safe and effective in combating COVID-19
  • National effort to facilitate the development of, and access to, investigational therapies derived from human blood
  • Make treatment options available to patients and providers who are not able to participate in clinical trials through expanded access under investigational drug (IND) applications

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New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19

> 130 clinical trials of potential COVID-19 related treatments and additional development programs for other agents are in the planning stages

  •  FDA has started to receive data from clinical studies and expects to receive more
  • Agency intends to engage with pharmaceutical sponsors and other government partners for expedited patient access when favorable results

2 Guidances


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Surveillance inspections during COVID-19

CDC collaboration to develop a process to return to on-site facility surveillance inspections in accordance with White House Guidelines for ‘Opening Up America Again’

  • First protect health and well-being of workforce and state contract inspectors as well as industry  health of workers
  • Communications with industry as well as domestic and foreign regulatory counterparts
  • Leadership team meet daily to discuss the urgent issues related to drugs/devices, medical and food product supply chains, leverage public health tools
  • Closely monitor global situation and remain in contact with domestic and foreign regulatory counterparts

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COVID-19 Updates: First Antigen Test for rapid detection, First Diagnostic Test using at-home saliva collection, Documents for Reopening, Updated COVID-19 resources

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Sofia 2 SARS Antigen FIA
First Antigen Test to Help in Rapid Detection of COVID-19 virus

Quidel Corporation

INDICATION: Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly

ADDRESSING AN UNMET NEED: 

  • New category of tests for use in ongoing pandemic
  • Quick detection of protein fragments found on or within the virus

DESCRIPTION: 

  • Lateral flow immunofluorescent sandwich assay for the qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens
  • SARS-CoV-2 nucleocapsid protein antigen is generally detectable in respiratory specimens during the acute phase of infection
  • Positive results are indicative of presence of SARS-CoV-2 nucleocapsid protein antigen, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
  • Negative results should be treated as presumptive and confirmed with a molecular assay

REGULATORY PATHWAY: Emergency Use Authorization

AUTHORIZATION


First Diagnostic Test Using At-Home Collection of Saliva Specimens

TaqPath SARS-CoV-2 Assay

Rutgers Clinical Genomics Laboratory

Spectrum Solutions LLC SDNA-1000 Saliva Collection Device

INDICATION: Qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal (throat) swab, nasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, and bronchoalveolar lavage (BAL) fluid from individuals.  This test is for use with saliva specimens that are self-collected at home with the LLC SDNA -1000 collection device

ADDRESSING UNMET NEED: First diagnostic test where nasal specimens can be collected at home

DESCRIPTION:

  • Qualitative test for detection of nucleic acid from SARS-CoV-2
  • Self-collection saliva specimens at home or in a healthcare setting
  • SARS-CoV-2 nucleic acid generally detectable in respiratory specimens during the acute phase of infection
  • Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to
    determine patient infection status
  • Positive results do not rule out bacterial infection or coinfection with other viruses

REGULATORY PATHWAY: Emergency Use Authorization

AUTHORIZATION


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Documents to support Reopening

FDA issued documents designed to assist retail food establishments in preparing to reopen

  • Help businesses that prepare food to serve or sell to the public directly, such as restaurants, bakeries, bars and carry-outs, protect employee and public health as they reopen for business

Food Safety Checklist

Infographic 


Updated COVID-19 Resources

FAQs on Testing for SARS-CoV-2

FDA COVID-19 Response: At-A-Glance Summary


Image credit: FDA

COVID-19 Updates: Remdesivir, Convalescent plasma, Tips & FAQs (EUAs, Alcohol-based hand sanitizer, Medical Countermeasures Initiative, Grocery shopping, Pet safety

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REMDESIVIR injection

Gilead

AUTHORIZED USE: Treatment of patients hospitalized with suspected or laboratory confirmed SARS-CoV-2 infection and severe disease.

Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.

MECHANISM OF ACTION: Nucleoside ribonucleic acid (RNA) polymerase inhibitor that inhibits viral RNA synthesis; activity in cell culture and animal models against SARS-CoV, MERS-CoV, and SARS-CoV-2

EFFICACY:

NIAID-sponsored randomized, double-blinded, placebo-controlled trial

  • Randomized, double-blind, placebo-control, remdesivir vs. placebo, n= 1063 hospitalized patients
  • Primary clinical endpoint: Time to recovery within 28 days after randomization
  • Preliminary analysis:  Median time to recovery was 11 days (remdesivir) vs. 15 days (placebo) p<0.001), Mortality was 8.0% (remdesivir) vs. 11.6% (placebo), p=0.05

Gilead-sponsored open-label trial

  • Randomized, open-label multi-center clinical trial, n~400 with severe COVID-19 with 5-day or 10-day treatment
  • Primary clinical endpoint: Clinical status assessed by 7-point ordinal scale at Day 14 after randomization
  • Preliminary Analysis: Similar improvement in clinical status in both groups

SAFETY:

  • Hepatic adverse reactions: Transaminase elevations, ALT and AST, need for appropriate clinical and laboratory monitoring

REGULATORY PATHWAY: Emergency Use Authorization

  • SARS-CoV-2 can cause  serious or life-threatening disease or condition
  • Based on the totality of scientific evidence available to FDA, it is reasonable to believe that remdesivir may be effective in treating COVID-19
  • There is no adequate, approved, and available alternative to the emergency use of
    remdesivir for the treatment of COVID-19

FACT SHEET  


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Investigational COVID-19 convalescent plasma

Providing  recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma

Donor eligibility

  • Evidence of COVID-19 documented by a laboratory test or positive serological test
  • Complete resolution of symptoms at least 14 days before donation
  • SARS-CoV-2 neutralizing antibody titers, if available

Patient eligibility

  • Laboratory confirmed COVID-19
  • Severe or immediately life-threatening COVID-19
  • Informed consent

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COVID-19 Tips and FAQs

What is Emergency Use Authorization

Updated EUA Webpage

Availability of alcohol-based Hand sanitizer

Medical Countermeasures Initiative (MCMi)

12 tips for grocery shopping

Pet safety


Image credit: Gilead, FDA