In 2018, the FDA published a draft guidance on how to develop drugs to treat early Alzheimer’s Disease (AD).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
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
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
Population pharmacokinetics (popPK) is the study of variability in drug concentrations within a patient population receiving clinically relevant doses of a drug of interest. PopPK methods use mathematical models to describe…
Read More
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…
Read More