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Tag Archives: analytical testing
Therapeutics for Rare and Neglected Diseases – How Rare is Rare?
The U.S. National Institutes of Health (NIH) classifies a rare disease as affecting less than 200,000 individuals in the United States. As insignificant as this classification may sound, collectively there are more than 25 million people in the United States … Continue reading
Posted in Clinical Trials, Regulatory Strategy
Tagged analytical testing, biomarker, clinical trials, dos, exclusivity, FDA, IND, NIH, novel therapeutic, Orphan Drug Designations, tax credit, toxicology
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Adaptive Designs and Clinical Supplies
In a recent post, John Johnson discussed the FDA’s draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics, particularly in the context of planning and designing a clinical trial. My perspective concerns challenges related to clinical supplies (CS) … Continue reading
Posted in Clinical Trials
Tagged adaptive design, adaptive trials, analytical testing, API, clinical supplies, clinical trials, drug product, FDA, guidance, labeling, manufacturing
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