Biosimilars: How the Approval Process Differs from a Standard ANDA
When seeking regulatory review and approval of a biosimilar, it is critical…
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Why It’s Smarter to Play the Long Game When Planning...
The drug development process is long and expensive. You are doing yourself…
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How to Ensure Your Device, Software, and Drug Are All...
Our experts are taking you through everything you need to consider to…
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The Unique Challenges of Gaining Approval for Drug-Device Combos
There are many challenges to getting a drug-device combination approved by the…
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505(b)(1) vs. 505(b)(2): Choosing the Appropriate Regulatory Pathway
Choosing the right regulatory pathway is critical to the success of your…
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What You Need to Know About the ICH
Our experts are sharing details about the ICH, its purpose and history,…
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The Human Factor – Preparing Your Device for Usability Testing
Usability studies that take the "human factor" into consideration are essential for…
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Understanding Bioequivalence and Product-Specific Guidances
Your guide to understanding product-specific guidances for generic drugs that are bioequivalent…
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