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.
About a New Chemical Entity (NCE)
A New Chemical Entity (NCE) is a drug that does not contain an active ingredient that has been approved by the U.S. Food and Drug Administration (FDA) with any other application submitted under 505(b)(1) regulatory pathways. NCEs are generally developed during the early discovery stage of the product cycle, then undergo various clinical trials that can transform the active ingredient into a product. All investigations supporting safety and effectiveness, both clinical and non-clinical, under 505(b)(1), are conducted by or on behalf of the Sponsor. The FDA can provide exclusivity to an NCE so no other manufacturer can apply for a product with the same active ingredient 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.
Drug Application Process for Direct to Nonprescription or direct-to-OTC Drugs
Under the drug application process, a sponsor of a nonprescription drug submits a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) to FDA for approval. The sponsor cannot market the nonprescription drug until FDA approves the NDA or ANDA. One important difference between a drug application for a prescription drug and a nonprescription drug is that consumer behavior studies are often needed to demonstrate that consumers can use the nonprescription drug product safely and effectively without the supervision of a healthcare provider. The consumer behavior studies conducted by a sponsor of nonprescription drug typically include: label comprehension, self-selection, actual use, and human factors studies. FDA encourages all potential drug sponsors to initiate contact with the Office of Nonprescription Drugs (NDA products) or the Office of Generic Drugs (ANDA products) as early as possible, so that drug sponsors can consider FDA’s product development recommendations.