Technical / White Paper

Seeking Drug Approval via the 505(b)(2) NDA Option

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Seeking Drug Approval via the 505(b)(2) NDA Option

Today, many pharmaceutical companies are choosing the 505(b)(2) New Drug Approval (NDA) regulatory pathway. The 505(b)(2) NDA route relies on investigations not conducted by or for the applicant, or on investigations for which the applicant has not obtained a right of reference or use from the person who conducted the original investigations. To submit 505(b)(2) NDAs, applicants rely on published literature of clinical studies and/or the FDA’s filing of safety and efficacy data for a previously approved drug. Many pharmaceutical companies remain unaware of the resources required to maximize the benefits of 505(b)(2) applications. Contracting integrated 505(b)(2) NDA services to fulfill the complex requirements is therefore usually very cost- and time-effective.

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