On Wednesday, March 11, 2020, the World Health Organization declared the spread of the respiratory illnesses caused by the novel coronavirus a pandemic. The impact of COVID-19 is being felt at home, at work, and across the globe.

Pharma and medical device firms are taking precautionary actions that impact day-to-day operations. FDA and other global regulatory agencies are publishing new guidance as well as ceasing international inspections. Here, we summarize the effect of COVID-19 in our community.

What Our Customers Are Doing

We asked our customers what they are doing in response to COVID-19.  Everyone is doing much of the same things:

  • Travel Restrictions: All non-essential travel banned through April.
  • Work from Home: If they have done so already, teams are organizing to work remotely through April.
  • Supply Chain: It’s too early to say whether supply chains have been impacted, but so far we are unaware of any effect for the customers we have spoken with.
  • Current Business: So far no impact on product sales or business with the exception of how business is being conducted. Companies are leveraging teleconferences and virtual meetings until the travel bans are lifted.

FDA and Global Response

In last week’s edition of the GMP Regulatory Newsletter by Barbara W. Unger, she provided the following links to what the global response has been so far:

Also, you can read more about FDA’s latest move halting overseas inspections of drugs and devices, citing COVID-19, from the New York Times here

Image source: Johns Hopkins University & Medicine

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