November 2020

Updates to U.S. FDA Legislation and Guidance – July to November 2020

Learn more about the FDA’s focus, including COVID-19 pandemic response and drug development programs in this update from Marinka Tellier.

During this quarter, the FDA’s main focus remained on responding to the COVID-19 pandemic and posting major COVID-related activities in a daily roundup and on the dashboard for the Coronavirus Treatment Acceleration Program (CTAP), a special emergency program for potential coronavirus therapies. At present, more than 590 drug development programs are being reviewed, which includes over 310 trials (excluding vaccines), and authorization of five COVID-19 treatments under Emergency Use Authorizations (EUAs). The variety of treatment modalities being evaluated are shown below. In October, Remdesivir was the first FDA approval of a treatment for selected COVID-19 patients following initial authorization under a EUA. In addition, as part of oversight of COVID-19 tests, the FDA has authorized a large number of COVID tests under EUAs inclusive of 223 molecular tests, 57 antibody tests and seven antigen tests to date. This included the issue of a EUA on November 17 for the first COVID-19 rapid diagnostic test for self-testing at home. The FDA continues to monitor authorized tests and, based on available data, may revise and revoke tests based on their benefit/risk profiles.

Source: FDA CTAP dashboard

The FDA held a key meeting of the Vaccines and Related Biological Products Advisory Committee on October 22 to publicly discuss the general development of COVID-19 vaccines. This included discussion of the draft FDA guidance issued in October 2020 for the EUA of COVID-19 vaccines, which details expectations of the primary efficacy endpoint that would need to be met. In addition, it was discussed that EUA authorization for a COVID-19 vaccine would not be contingent on a facility inspection. FDA has yet to issue an EUA for a COVID-19 vaccine, but vaccine developers are getting closer with anticipated filings by the end of the year.

The FDA has published more than 60 COVID-19 related guidances, with the following significant publications issued during this quarter:

  • Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers
  • Investigational COVID-19 Convalescent Plasma: Guides the clinical investigation of plasma derived from individuals recovered from COVID-19 as treatment for those with severe COVID-19 infection.
  • Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment (FINAL): Provides guidance on patient recorded outcomes and scale used to rate the severity of assessments.
  • Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency

To protect consumers from fraudulent or unsafe products, the FDA identified over 1,100 fraudulent products and sent warning letters to companies marketing unapproved products for the treatment of COVID-19 and to producers of hand sanitizers found to contain less than the required amount of alcohol or to contain methanol or 1-propanol which can be toxic and life threatening when ingested. The FDA also warned consumers about hand sanitizers packaged in food and drink packages, which could lead to inadvertent use. To aid consumers, the FDA has published a list of hand sanitizers that should not be used.

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