The FDA 505(b)(2) New Drug Application (NDA) used to be called a “Paper” NDA. The 505(b)(2) allows companies to develop alternative therapies more quickly because they can rely on published literature that supports the approval of the application and FDA’s finding of safety and effectiveness of an approved drug.
The 505(b)(2) applicant can change a product’s route of administration from subcutaneous injection to oral administration.
The applicant relies on the safety data established for the drug’s subcutaneous injection that has been approved by the FDA; however, the applicant will conduct clinical trial studies showing safety and efficacy that relate to oral administration of the drug.
Additional information may be required to show comparability.
Compliance Insight can assist you with your 505(b)(2) application. Call our office today.