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2019 - 505(b)(2) NDAs

Date2019-03-26

Deadline2019-03-26

VenueOnline Event, USA - United States USA - United States

Keywords505(b)(2) nda; Fda 505 (b)(2) nda; 505(b)(2) submission

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

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: 2019-03-13 20:54:55