What is the abbreviated new drug application?
04/12/2021
Category: Other Blogs
An abbreviated new drug application (US FDA ANDA) is a written request an organization sends to the U.S. food and drug administration...
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Avoiding an FDA 483 at a Pre-Approval Inspection for NDA & ANDA
03/08/2019
Category: Good Industry Practices
Every US FDA ANDA or NDA application requires time and money to develop drugs that will enter the U.S. market. Imagine spending...
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