Surrogate Endpoints – Neither the End nor the Point
In an article published in June 2018 in JAMA Oncology, the FDA reviewed their accelerated approvals for malignant hematology and oncology drugs over the previous 25 years. In an earlier…
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What to Expect following Your Marketing Application Submission
Submitting a marketing application to the FDA is only the first in a cascade of events that lead to products being approved. However, this flurry of activity is not solely…
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Alzheimer’s Drug Development & Challenges to the Amyloid Hypothesis
In 2018, the FDA published a draft guidance on how to develop drugs to treat early Alzheimer’s Disease (AD). This document came in the wake of several high-profile late‑stage failures…
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Federal and Regulatory Support for the Development of Novel Antibiotics
Antibiotics are among the most important medications in the modern healthcare toolbox and are essential safeguards against global pandemics. However, antibiotics can be challenging to develop, and more and more…
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Regulatory Submissions: Hints and Common Mistakes for eCTD Submission
The electronic common technical document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and the Center for…
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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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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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