In today’s competitive healthcare landscape, shortening your product’s time to market can significantly improve commercial success. Special FDA designations facilitate the development and expedite review of products that address unmet medical needs in serious or rare conditions, including qualified infectious disease products and products that provide significant advancements compared to existing treatments.
Kinexum assists in designing robust clinical trials and preparing compelling applications that showcase the clinical evidence supporting any FDA designation.
We identify risks early and help you mitigate them to increase the likelihood of FDA acceptance and approval. Our consultants stay abreast of evolving FDA guidelines to ensure that your application meets the highest standards of regulatory compliance.
At Kinexum, we guide companies through the intricacies of designations, including:
BREAKTHROUGH
This designation is for products that with clinical evidence of improvement in safety and/or efficacy compared to existing treatments. It provides enhanced FDA communication and shorter time to market, contingent on confirmatory evidence.
FAST TRACK
This designation is for products addressing unmet medical needs in serious conditions. It requires some nonclinical or clinical data and provides enhanced FDA communication and shorter time to market, contingent on confirmatory evidence.
PRIORITY REVIEW
This designation is for products addressing unmet medical needs in serious conditions and for certain pediatric drugs. It typically reduces review time from 10 months to 6 months.
ACCELERATED APPROVAL
This pathway allows for conditional approval of a product based on surrogate endpoints reasonably likely to predict clinical benefit, contingent on confirmatory evidence.
ORPHAN
This designation is for products addressing for rare diseases and includes tax credits, increased market exclusivity and communication with FDA, and flexibility in clinical trial design.
