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2019 - 505(b)(2) NDAs

Date2019-02-27

Deadline2019-02-27

VenuePalo Alto, USA - United States USA - United States

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

Websitehttps://www.complianceonline.com/505b2-n...

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