Expedited Regulatory Programs

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Expedited regulatory programs offered by FDA and EMA can provide an opportunity for shorter new drug development, meaning that drugs can potentially reach markets and patients faster. Therefore, Sponsor companies should seriously consider not only the drug development journey but also how to optimize it through the use of one or more expedited programs mentioned below.

BLA Regulatory can help our clients understand the eligibility of their products and provide effective solutions to take advantage of one of the following mechanisms offered by the FDA and EMA. We will work with our clients to expedite both the drug development process and marketing application review timelines for promising drugs intended to treat serious diseases and unmet medical needs.

FDA EMA Advantage
Fast Track Designation (FTD)
Breakthrough Therapy Designation (BTD)
PRIORITY MEDICINES (PRIME) Decreasing Drug Development Timelines
Priority Review Accelerated Assessment Decreasing Application Review Time
Accelerated Approval Conditional Approval Preliminary Approval Pending Additional Data
Exceptional Circumstances Approval Based on a Limited Data