miércoles, 25 de marzo de 2020

FDA Medical Countermeasures Initiative Update

Coronavirus Disease 2019 (COVID-19) Update

FDA is an active partner in the coronavirus disease (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, and with our international counterparts. Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update on March 18, 2020 include:

Coronavirus (COVID-19) Updates:

March 24, 2020 - Daily roundup (on a variety of FDA actions)
March 24, 2020 - FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers
March 24, 2020 - FDA Helps Facilitate Veterinary Telemedicine During Pandemic
March 23, 2020 - Daily roundup (on a variety of FDA actions)
March 22, 2020 - FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency
March 22, 2020 - FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators
March 21, 2020 - FDA Issues first Emergency Use Authorization for Point of Care Diagnostic
March 20, 2020 - FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits
March 20, 2020 - FDA allows expanded use of devices to monitor patients’ vital signs remotely
March 20, 2020 - FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health
March 19, 2020 - FDA Continues to Facilitate Development of Treatments
March 19, 2020 - Blood Donations
March 18, 2020 - FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections
March 18, 2020 - FDA Issues Guidance for Conducting Clinical Trials

COVID-19 Updates from FDA

FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development

FDA and the European Medicines Agency (EMA) jointly chaired the first global regulators meeting to discuss regulatory strategies to streamline the development of SARS-CoV-2 vaccines. (March 23, 2020)

Read this FDA Voices

Emergency Use Authorization (EUA) Updates

Reminder: FDA Sets up 24/7 Hotline to Help Labs with Diagnostic Test Issues

FDA’s 24/7 hotline (1-888-INFO-FDA, choose option *) is available for labs to call regarding difficulties obtaining supplies for collecting patient samples for COVID-19 testing, including swabs and media needed for transport and conservation of the samples.

16 diagnostic EUAs issued to date

In the COVID-19 pandemic, the FDA has worked with more than 160 test developers who have said they will be submitting applications to make tests that detect the virus. To date, 16 EUAs have been issued for nation-wide use--7 in the last week, including the first point-of-care diagnostic. Under our laboratory developed test policy (PDF) during COVID-19, the FDA has been notified by more than 65 laboratories.

Today! March 25, 2020, 3:00 - 4:00 p.m. ET

FDA will hold a Virtual Town Hall for the Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

Non-NIOSH Approved Respirator EUA (March 24, 2020)

In response to this evolving public health emergency and continued filtering facepiece respirator (FFR or respirator) shortages, FDA has concluded based on the totality of scientific evidence available that certain imported disposable FFRs that are not NIOSH-approved are appropriate to protect the public health or safety (as described under section II Scope of Authorization) under section 564 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360bbb-3). Under this EUA, authorized respirators listed in Exhibit 1 are authorized for use in healthcare settings by healthcare personnel (HCP) when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak.