Tuesday, June 9, 2020

FDA Roundup: Coronavirus (COVID-19) Update: Daily Roundup June 8, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • On June 6, 2020, in response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the FDA issued certain Emergency Use Authorizations (EUAs) to revise which respirators the decontamination systems are authorized to decontaminate. The FDA also reissued two EUAs covering imported respirators by tightening other criteria in the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China as well as in the Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators.
  • The FDA issued a guidance, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.” The guidance addresses questions FDA has received concerning prescription drug sample distribution under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency. The guidance explains that, on a temporary basis, the FDA does not intend to object to the delivery of prescription drug samples to patients’ homes if requested by their licensed health care professional, and the guidance describes the agency’s current policy regarding the signature required at time of delivery of drug samples, to promote public health.
  • On June 8, 2020, the FDA added the BioMedInnovations SuppleVent Ventilator to the list of ventilators authorized under the March 24, 2020, EUA for certain ventilators, ventilator tubing connectors, and ventilator accessories. This ventilator provides continuous ventilatory support for adult patients who require mechanical ventilation. The ventilator is intended for institutional use by qualified, trained personnel under the direction of a doctor. Institutional use includes use in an intensive care unit or other hospital environments such as during intra-hospital transport and in temporary hospital facilities. Lawrence Livermore National Laboratory collaborated in the design of the ventilator.
  • FDA published two new web pages to help the public access information: (1) Innovation to Respond to COVID-19 provides an overview of FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible and (2) Educational Resources provides links to FDA-produced COVID-19-related resources that help explain FDA’s work.
  • Testing updates:
  • To date, the FDA has authorized 125 tests under EUAs, which include 107 molecular tests, 17 antibody tests, and 1 antigen test.

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