Fast Track Designation 

The Fast Track Designation program is specially designed to help accelerate drugs and therapies intended to treat serious diseases to market. Authorized by the FDA in 1997, this program has enabled life-saving treatments to “jump to the front of the line”, receiving the necessary attention and reviewal from the administration in hopes of being approved for use. 

Through this program, pharmaceutical companies and developers gain more direct communication with the Agency and expedited timelines regarding their therapy passing through FDA protocols. This designation opportunity isn’t one to take lightly as this priority treatment is highly sought after by many within the industry. Therefore, drug sponsors submitting to the FDA need to ensure: 

    1. Drug treats a serious condition and fulfills an unmet medical need 
    2. The clinical study designs adequately investigate the drug 
    3. Clinical data shows sizable efficacy and significant improvement over other drugs in the market for the same condition 

Download our white paper to learn more about how to obtain and capitalize on a Fast Track Designation. 

Fast Track Designation White Paper

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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.