Year in Review: Reflecting on the Biggest News Stories & Events in 2020

  • December 18, 2020
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2020 has been an odd year. This year has been different, challenging, difficult, and so much more – the list could go on for days. And yet, we there are extremely memorable and noteworthy topics to review. From the COVID-19 pandemic and all that has gone along with the global health crisis, to the Food […] READ MORE...

Preparing for Regulatory Success in 2021

  • December 10, 2020
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As we all begin to wrap up the year and look ahead to 2021, it is critical to make sure your team is prepared for what is coming in the weeks and months that lay ahead. Preparation and preparedness are key to ensuring regulatory success at any point, but especially as we approach a new […] READ MORE...

A Roadmap to Authorization: Using Science to Prepare a MAA

  • November 17, 2020
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As you move from Phase 3 clinical trials towards your Marketing Authorization Application (MAA), there are a number of critical steps that must be taken regarding how you interpret your clinical trial results and then present that information to the European Medicines Agency (EMA). In order to prepare for your Centralized MAA, it is critical […] READ MORE...

Scientific Data Works: Using Science to Navigate the Global Regulatory Maze

  • November 11, 2020
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You’re developing an FDA- and/or EMA-regulated drug, biologic, or medical device. Throughout the drug development process, your goal is to get to the next regulatory milestone in the most expeditious way possible. The best way to do this? Using your data to tell a compelling story. Evolution of Regulatory Sciences The process of developing a […] READ MORE...

Filing Using Registry-Based Studies? EMA Issues Draft Guidance

  • October 26, 2020
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Recruiting clinical studies in a niche disease area can be challenging, but disease registries can provide the solution.  The European Medicines Agency (EMA) has issued a draft guidance on how registry-based studies can support marketing applications, and the practical details that Sponsors need to consider. Data from disease registries can provide vital support for regulatory […] READ MORE...

The Key to Understanding Pricing and Reimbursement in the Nordics

  • October 16, 2020
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It is easy to think that when you finally receive market approval for your drug, you have reached the finish line.  However, what many do not realize is that there is still a final hurdle that can be both challenging and sometimes complicated to accomplish – getting reimbursement granted and thereby gaining access to the […] READ MORE...

10 Things You Need to Know about FDA’s Final Rule on Importing Prescription Drugs from Canada

  • October 6, 2020
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Last week, FDA issued a final rule regarding the importation of certain prescription drugs from Canada.  This action was taken by the agency as part of the Safe Important Action Plan, and was done in an attempt to provide safe, effective, and more affordable drugs to Americans. The final rule was published alongside a final […] READ MORE...

Biosimilars: How the Approval Process Differs from a Standard ANDA

  • September 9, 2020
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Biosimilars, by their very nature, are different from generic drugs. The core difference is that generic drugs are chemically synthesized, while biosimilars are grown in complex living systems. Because of this difference, generic drugs are reviewed and approved under the abbreviated new drug application (ANDA) pathway and biosimilars are reviewed and approved under the 351(k) […] READ MORE...

How to Ensure Your Device, Software, and Drug Are Ready for a Pre-Approval Inspection

  • August 31, 2020
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When drug or device manufacturers apply for marketing approval of a new product, the FDA may conduct a pre-approval inspection (PAI). The PAI is performed to help the Agency assure that a manufacturing facility named in an application can manufacture the product, and that the submitted data are accurate and complete. Ultimately, the purpose of […] READ MORE...

What You Need to Know About the ICH

  • August 20, 2020
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The FDA has a strong interest in promoting the health and safety of U.S. citizens; in addition, it also supports the advancement of the global harmonization of regulatory requirements and practices. To accomplish this goal, the FDA has partnered with regulatory bodies of several other countries to form the International Conference for Harmonisation of Technical […] READ MORE...