ResearchBib Share Your Research, Maximize Your Social Impacts
Sign for Notice Everyday Sign up >> Login

2019 - 505(b)(2) NDAs



VenuePalo Alto, USA - United States USA - United States

Keywords505(b)(2) nda; 505(b)(2) product qualificatio; 505(b)(2) new drug application


Topics/Call fo Papers

What is a 505(b)(2) NDA
What products qualify for submission under 505(b)(2)
Examples of data and information that may be referenced
Requirements for studies to be conducted
Submission content requirements
Limitations to and benefits of a 505(b)(2)

Last modified: 2019-01-29 17:39:36