Expedited Programs Explained: How to Expedite Product Approval in the US and Europe
In an attempt to combat the overwhelming amount of conditions with either no or extremely limited treatment options, regulatory agencies across the globe have developed a number of programs and regulatory tools designed to expedite the approval of products likely to be of significant therapeutic benefit.
Could your product be eligible for one of these expedited programs?
Join us for our upcoming Insider Talks to find out! Register here
In the US, the FDA has developed four expedited programs – Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review. In Europe, applicants may be able to bring cutting edge treatments to patients with high unmet needs more rapidly through the use of conditional marketing authorization, PRIME, or an accelerated assessment. In situations where it is not feasible or ethical to collect comprehensive data, approval under exceptional circumstances may be possible.
After Brexit, the UK has a new innovative pathway that also incorporates market access. Although the principles that all these programs are grounded in are similar, the processes, submissions, and timelines are vastly different.
Participants will gain a better understanding of:
What expedited programs are and why they are important
Which expedited programs are available to Sponsors in the United States vs. Europe (EU and UK)
Procedures and timelines in both regions
How to determine whether your product is eligible for any of these programs
Interested in learning more? Register today and join us for this complimentary live webinar!