A previous entry detailed Dried Blood Spot Analysis: Preclinical Pros and Cons. Additional preclinical considerations include the ambiguity of acceptance by global regulatory agencies, none of which have issued definitive rulings on how they’ll handle New Drug...
In order to keep our competitive edge, the Federal Drug Administration (FDA) is placing increased emphasis on strengthening both the field and application of regulatory science relative to pharmaceutical research, development, review, and post-market surveillance. ...
Both advantages and challenges exist for use of dried blood spots during preclinical drug development. Advantages include small sample volumes coupled with easy shipment and storage. The amount of blood per spot varies (10 to 100 μL), but use of 15 to 20 μL seems...
All medical products pose risks and postmarketing surveillance is critical to expanding the limited evidence base that exists when new drug products are approved. Through initiation of the Sentinel Initiative (May 2008), the Food and Drug Administration (FDA) is...
FDA approval does not mean that a drug works well; it means only that the Agency deemed its benefits to outweigh its harms. Comparative efficacy data, other than to placebo, may be missing from the label. In 2006, the FDA revised the drug label design, adding a...
FDA commissioner Dr. Margaret Hamburg launched a new initiative to innovate regulatory science so that it can keep pace with the evolution of biomedical research. New pilot and feasibility studies are proposed to investigate early drug safety and efficacy. In...
