ProPharma Group and The Planet Group announce unified brand and expanded capabilities. Learn more >

Whitepaper

What You Need to Know About Programs for Expedited Approval

Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product.

The development and approval of novel drugs typically means new and life-saving treatment options for patients suffering from rare diseases. Although we know the importance and value of novel drug development, there are many diseases lacking adequate therapies and treatments.

To encourage innovation for these conditions, the FDA and EMA created various mechanisms to expedite the approval of drugs that have not previously been used in clinical practice. Some of these include:

  • Fast Track Designation
  • Breakthrough Therapy Designation
  • Priority Review
  • Accelerated Approval
  • PRIME Designation

Each of the above-mentioned mechanisms expedites the approval process, however they are not all created equal, which can make it difficult to determine the best option(s) for your product. Download our whitepaper to learn which option(s) may be most appropriate for you.

 

Get this Whitepaper

Click the button below to download your materials.

Get Whitepaper

For additional information from our team of industry-leading experts,
visit our Resources page.


All fields are required.
There was a problem with your submission. Errors have been highlighted below.
By submitting this information, you consent to use in accordance with our Privacy Notice.