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  5. Center for Drug Evaluation and Research Response to Coronavirus (COVID-19) | Infographic
  1. Coronavirus (COVID-19) | Drugs

Center for Drug Evaluation and Research Response to Coronavirus (COVID-19) | Infographic

Visualization of data associated with CDER's response to the coronavirus (COVID-19) pandemic from January 1, 2020 – September 30, 2021

Timeline: January 1, 2020 – September 30, 2021

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Center for Drug Evaluation and Research Response to COVID-19

COVID-19 Therapeutic Development

  • 640+ drug development programs in planning stages
  • 470+ trials reviewed by FDA
  • 11 treatments currently authorized for emergency use 
  • 1 treatment currently approved by FDA

Regulatory Flexibility

Proactively issued temporary policies to address the pandemic and provide regulatory flexibility on:

  • Certain drugs compounded for hospitalized patients with COVID-19 
  • Repackaging or combining Propofol
  • Prescription Drug Marketing Act requirements for distributing prescription drug samples
  • Drug Supply Chain Security Act requirements

Generic Drug Approvals (Abbreviated New Drug Applications)

Approved 1,000+ original and supplemental generic applications for COVID-19 related treatments and supportive therapies

Addressing fraud

Took action against sellers of fraudulent products for the treatment or prevention of COVID-19 and issued more than 120 warning letters

Internet pharmacies

Issued 17 warning letters to operators of websites that sell unapproved and misbranded COVID-19 products

Hand sanitizer

Published a list with more than 250 listings of hand sanitizers consumers should not use, including those containing potentially dangerous contaminants

Shortage mitigation activities

Continued outreach to more than 180 manufacturers relating to manufacturing capacity and supply chain for both COVID-19 and non-COVID-19 treatments

Surveillance and Epidemiology

Examined and analyzed data across at least 15 data sources, including 55,000 adverse event reports to monitor drug safety and medication errors

U.S. Public Health Service Corps deployment

Approximately 364 CDER Commissioned Corps officers fulfilled 623 deployment requests in support of the COVID-19 mission

Engagement with stakeholders

CDER fielded 23,515 COVID-19 drug related inquiries from the general public, including health care providers, consumers and manufacturers


For more information, please visit www.fda.gov/drugs

 
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