The FDA’s New Draft Guidance: Is Your Exhibit Ready for the Change?

So, the FDA (Food & Drug Administration) has released Draft Guidance on the Accelerated Approval Process for Serious Conditions. What exactly is that?

The guidance emphasizes and is trying to provide clarity on the following:

• Stronger evidence requirements, including the use of randomized controlled trials over single-arm studies when feasible. Here’s what that means. A randomized controlled trial (RCT) compares two or more groups, where participants are randomly assigned to receive either the treatment or a placebo/standard care, making results more reliable. A single-arm study tests a treatment in just one group without comparison, which can make it harder to know if the treatment truly works. The FDA prefers RCTs when possible because they provide stronger, more trustworthy evidence.
• Early planning for confirmatory trials to verify clinical benefit post-approval. Essentially this means drug companies must plan follow-up studies early to prove the treatment actually works after it's been approved.
• Potential enforcement actions if sponsors fail to complete required studies, which means if drug companies don’t finish the required follow-up studies, the FDA can take action, like pulling the drug from the market.

This aligns with the FDA’s push for more rigorous and transparent accelerated approvals, ensuring faster access to treatments while making sure the drug stays safe and works as expected.

The new parts of the FDA's accelerated approval process include:

1.????? Early Talks on New Measures – Encouraging drug companies to work with the FDA early to decide which test results can show a treatment is working. This has always been part of the process, but now the FDA is making it more official by requiring earlier and more structured talks with drug companies, especially about new ways to measure if a drug is working.

2.????? Quick Start for Follow-Up Studies – Making sure required follow-up studies begin as soon as the drug gets accelerated approval, with clear goals and deadlines.

3.????? Faster Approval Reversal – Speeding up the process of pulling a drug’s approval if follow-up studies show it doesn’t work or if rules aren’t followed.

4.????? Clear Post-Approval Study Rules – Setting strict timelines and reporting requirements for follow-up studies before granting approval.

5.????? Tighter Marketing Oversight – Requiring drug companies to submit ads and promotional materials to the FDA for review within set deadlines.

So, what is the potential impact on exhibitions, events and tradeshow marketing, you might ask?

1.????? More Precise Messaging & Compliance – Companies at medical trade shows must ensure their marketing follows stricter FDA rules. Any claims about drugs with accelerated approval must include disclaimers about their limitations.

2.????? Increased Demand for Medical Meeting Engagement – More companies may attend medical conferences to discuss regulations with FDA officials and industry experts.

3.????? Stronger Focus on Data & Real-World Evidence – Exhibitors will need to highlight strong data, ongoing follow-up studies, and real-world results when promoting products under accelerated approval.

4.????? Heightened Scrutiny on Marketing Practices – Companies may need legal and regulatory experts at their booths to ensure all marketing materials meet FDA requirements.

5.????? Potential Impact on Sponsorships & Speaking Engagements – Companies seeking accelerated approval may invest in speaking opportunities and panel discussions to share insights on regulatory processes and clinical trials.

This guidance reinforces the need for strategic, complaint, and data-driven marketing at industry events, particularly in the pharma, biotech, and medical device sectors.

As the FDA tightens regulations, pharmaceutical companies must ensure their exhibits and marketing align with evolving compliance standards, focusing on data, ongoing trials, and regulatory transparency. Exhibit houses like Poretta & Orr, Exhibits | Events play a key role in helping clients navigate these changes, creating engaging, compliant booth experiences.

Need a strategic exhibit partner? Contact a member of the Poretta & Orr team to understand the potential impact of regulatory changes on your exhibit and event marketing!