Articles

Latest news and updates about the Medicare and pharmacy industries.

May 8: FDA Updates Policy on COVID-19 Antibody Tests

Posted on in Industry Updates by Amplicare Team

Plus, the latest pharmacy and healthcare news to know this week

The Story

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. 

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.

Other Articles

Posted on by Amplicare Team

June 5: Study: Pharmacist Workloads Increased in 2019

Study shows workloads of pharmacy staff increased in 2019, MA and Part D plan sponsors apply to lower insulin...
Continue Reading

Posted on by Amplicare Team

May 29: U.S. Pharmacies Prepare For Flu Vaccine Push

U.S. chain pharmacies expect high demand for flu vaccine this fall, HHS overrides state rules against pharmacist COVID-19 testing,...
Continue Reading

Posted on by Amplicare Team

May 22: CDC Warns of Impact of Lower Vaccination Rates

Low vaccination rates could lead to measles outbreak, majority of Americans changed healthcare plans due to the pandemic, and...
Continue Reading

Posted on by Amplicare Team

May 15: CMS Guidance Helps Medicare Pharmacies Address COVID-19 Testing

CMS adds guidance to help with COVID-19 testing, routine vaccinations for children are down, Abbott antibody test gets EUA,...
Continue Reading