A Roadmap to Authorization: Using Science to Prepare a MAA
It is critical to understand the key procedural milestones involved in the…
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Meet the Expert: Matthew Weinberg
Get to know Matthew Weinberg! In our latest colleague spotlight, he is…
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Scientific Data Works: Using Science to Navigate the Global Regulatory...
Regardless of geographical location, one constant that remains across all regulatory agencies…
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Why Drug Approvals Are Never Slam Dunks
In the world of the FDA, sure things don’t exist. But, our…
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Filing Using Registry-Based Studies? EMA Issues Draft Guidance
Recruiting clinical studies in a niche disease area can be challenging, but…
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How to Present Scientific Data That Generates Regulatory Approvals
The best path to regulatory success for your drug's development is to…
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The Key to Understanding Pricing and Reimbursement in the Nordics
Choosing the right Pricing and Reimbursement strategy, and doing so early in…
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10 Things You Need to Know about FDA’s Final Rule...
If you’re interested in importing an approved product to the United States…
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