505(b)(1) New Drug Application

**Semantic type:** Intellectual Product

**Definition:** A regulatory framework described by section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (CFR Title 21, Chapter 9) that is used to obtain approval for a new drug that contains previously unapproved active ingredients. The data in the application includes full reports of investigations of the drug's safety and effectiveness and is either owned by the applicant or is data for which the applicant has obtained a right of reference. The application submitted by the drug's sponsor includes comprehensive data from preclinical studies (laboratory and animal studies) and clinical trials (phase I, II, and III).

**Synonyms:** - 505(b)(1) NDA