Fast Track Designation 

The Fast Track Designation program is designed to accelerate to market drugs intended to treat serious diseases with an unmet medical need. Authorized by the FDA in 1997, this program has enabled life-saving treatments to reach the market quicker than the standard review period. Through the Fast Track Designation program, pharmaceutical companies gain increased communication with the FDA and the ability to submit portions of the marketing application prior to the complete submission, which allows for the drug’s expedited development and review. Additionally, if eligible, a Fast Track Designation may allow for the priority review of a marketing application.

Sponsors submitting a Fast Track Designation application to the FDA must ensure data are sufficient in demonstrating the therapy is intended to treat a serious condition and has potential to address an unmet medical need.

Download BioPharma Global’s Fast Track Designation white paper to learn more about the required criteria for application, the proper steps for submission to the FDA, and the associated benefits.

Fast Track Designation White Paper

How Regulatory Affairs Consultants Improve Approval Rates 

Hiring consultants specializing in a variety of FDA regulations and procedures benefits the Fast Track Designation process. Our team of experienced consultants at BioPharma Global has helped numerous drug sponsors successfully navigate the Fast Track Designation program and get their treatment to market in an expedited manner. Our staff has submitted hundreds of applications for a variety of indications and have a 100% FDA/EMA submission success rate when clients follow our instructions.

Who is BioPharma Global?

BioPharma Global is a full-service regulatory affairs consulting firm specializing in orphan products to treat rare diseases and non-orphan products to treat indications with unmet medical needs. We offer services such as orphan drug designations and other expedited review programs, provide support for meetings with the FDA and EMA, IND filings, and comprehensive consulting on projects for regulatory strategy.