Communicating Unpredictable Regulatory Milestones

As researchers work at a never-seen-before pace to develop a safe and effective COVID-19 vaccine, the FDA has taken center stage. Founded in 1906, the Food and Drug Administration is a federal agency of the Department of Health and Human Services. The agency is  responsible for protecting the public health by ensuring the safety and efficacy of human and veterinary drugs – which is where its role comes into play with the current race to find a COVID-19 vaccine.

And of course the FDA’s medical purview is much broader than vaccines. It is also responsible for regulating medical devices – everything from at-home genetic test kits to implanted heart pumps. For many companies, the approval milestones are cause for promotion and communication – to investors, to customers, to employees. Regulatory milestones include approval to begin rounds of clinical trials, clearance to commercialize and sell to consumers and approval to go to market via health care professionals.

Each of these milestones is an opportunity to communicate but, the “when” of communicating the news is where it becomes tricky. That’s because companies are often completely uncertain of if or when approval will occur. What’s more is that it is not out of the ordinary for the FDA to issue its own press release about a milestone, with or without a coordinated effort from the product’s company.

So how does a company, whose business success relies on leveraging regulatory milestones, prepare especially in a media landscape that is unpredictable and still dominated by coronavirus?

Here are a few tips to keep in mind:

Regulatory milestones are major accomplishments. They help inform the safety and efficacy of your product. So seize the opportunity to communicate to your business and medical stakeholders – just make sure you’re ready for it.

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