505B(2) Application Submission
Posted on30 Mar 2018
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The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways. The pathway was... Read More
ANDA Submission and Handling FDA Expectations
Posted on09 May 2015
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Regulatory Norms are ever-changing. There have been significant changes in FDA expectations of Abbreviated New Drug Applications (ANDAs) since the passage of... Read More