A human mass balance clinical study aims to understand how drugs are absorbed, metabolized, and excreted after dosing. This information is important because it helps determine other clinical investigations that…
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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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Although the implementation of laws surrounding the safety and efficacy of drugs and biologics started in the early 1900s, the inclusion of pediatric use in labeling has significantly lagged behind.…
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In 2018, the FDA published a draft guidance on how to develop drugs to treat early Alzheimer’s Disease (AD).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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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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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 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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