Intrinsic and Extrinsic Factors in Drug Development
Personalized medicine (also known as precision medicine) is one of today’s biggest drug development buzzwords. It certainly stirs the imagination – the notion that one day we may live in…
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FDA Policies to Accelerate Development of Cell & Gene Therapies
FDA Commissioner Scott Gottlieb, M.D. and Director of the Center for Biologics Evaluation and Research (CBER) Peter Marks, M.D., Ph.D., released a joint statement on January 15, 2019 previewing new FDA…
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The Path to IND Part 2: Supporting Clinical Study Design and Dosing
Introduction In part one of this blog series, “The Path to IND Part I: Milestones and Common Roadblocks,” we introduced the FDA’s Investigational New Drug (IND) application and highlighted some…
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Former FDA Reviewers Provide Answers to Key Questions: Part 2
by Gene Williams and Brian Furmanski Two of Nuventra’s consultants, Gene Williams and Brian Furmanski, spent a combined 23 years working at the FDA. In Part 1 of this blog…
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The Path to IND Part 1: Milestones & Common Roadblocks
The Investigational New Drug (IND) application is the primary pathway through which new drugs and biologics are approved to be tested in humans. But, what exactly is an IND and…
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Why Do Clinical Trials Fail?
by Scientific Writing Team Large quantities of time, money, and intellectual capital are expended to plan and execute clinical trials. Yet, despite all of these investments, clinical trials don’t always…
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Abbreviated New Drug Application vs. 505(b)(2) NDA: Choosing the Right Path
by Scientific Writing Team Media attention and investor fanfare in drug development tend to focus on novel therapies. But did you know that these therapies only account for a small…
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