Plus, the latest pharmacy and healthcare news to know this week
The Food and Drug Administration (FDA) has new requirements for COVID-19 antibody or serology test developers. The updated policy addresses reports of concerns with many tests currently on the market.
Why It Matters
The FDA’s initial policy, issued in March, provided flexibility which allowed for early use of antibody tests. However, the agency noted that it has since learned of commercial serology tests being promoted inappropriately or performing poorly.
You could also read this
Per the updates, commercial manufacturers of antibody tests must submit Emergency Use Authorization (EUA) requests with their validation data within 10 business days. The FDA also provided specific performance threshold recommendations for test developers and is introducing a more streamlined process for EUA submissions and review.
Currently, 12 antibody tests have been authorized under an individual EUA and over 200 are in review. With multiple unauthorized tests available, pharmacies offering COVID-19 tests should do their due diligence before ordering tests. In addition to industry resources, the FDA also compiles a list of current and terminated EUAs to help.
Other healthcare news to know:
1. Famotidine has been added to the FDA’s drug shortage list after reports it was being tested as a possible COVID-19 treatment. Bloomberg.
2. CMS issues more regulatory waivers and rule changes to expand Medicare beneficiaries’ access to care during COVID-19. Healthcare Finance.
3. The FDA rings the alarm about fake online pharmacies. Charlotte Observer.
4. NCPA’s “Your Neighbor” campaign highlights the efforts of community pharmacists. Drug Topics.
5. Remdesivir gets emergency use authorization for COVID-19 treatment. STAT.