In 2018, the FDA published a draft guidance on how to develop drugs to treat early Alzheimer’s Disease (AD).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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More