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Regulatory Affairs Blog Posts

September 9, 2020 Regulatory Affairs

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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August 31, 2020 Regulatory Affairs

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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August 25, 2020 Regulatory Affairs

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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August 17, 2020 Regulatory Affairs

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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August 12, 2020 Regulatory Affairs

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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August 5, 2020 Regulatory Affairs

What You Need to Know About the ICH

Our experts are sharing details about the ICH, its purpose and history,…

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July 28, 2020 Regulatory Affairs

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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July 22, 2020 Regulatory Affairs

Understanding Bioequivalence and Product-Specific Guidances

Your guide to understanding product-specific guidances for generic drugs that are bioequivalent…

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