About the 505(b)(2) regulatory pathway
The 505(b)(2) regulatory pathway is a type of New Drug Application (NDA) submission that encourages further innovation of drugs that have already received approval from the U.S. Food and Drug Administration (FDA). This pathway allows for faster approval times as it can avoid unnecessary duplication of studies that were already performed on approved drugs.
A 505(b)(2) NDA contains full safety and effectiveness reports, however the FDA can rely on other data not developed by the NDA applicant when considering drug approval. This data, like safety and efficacy information, can come from other studies of previously approved pharmacological agents that are similar in nature.
Virpax utilizes this unique regulatory pathway by applying our proprietary and patented delivery-systems and innovative technology to previously-approved drugs. We are then able to accelerate the development and approval process of our products.
About a New Chemical Entity (NCE)
A New Chemical Entity (NCE) is a drug that does not contain any active moiety that has been approved by the U.S. Food and Drug Administration (FDA) with any other application submitted under 505(b) regulatory pathways. NCEs are generally developed during the early discovery stage of the product cycle, then undergo various clinical trials that can transform the drug into a product. The FDA can provide exclusivity to an NCE so no other manufacturer can apply for a product with the same active moiety for a determined amount of time.
Rare Pediatric Disease (RPD) Designation and Voucher Programs
Under Section 529 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. Under this program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.