Drugs

Stakeholder Exposure-Response Analysis Comments

Four drug industry stakeholders have provided detailed responses to an FDA request for comments on exposure-analysis in drug development and regulatory decision making. Pfizer suggests that the updated exposure-response guidance primarily focus on “what” and “why” elements and advance the 2003 version by citing illustrative examples that have entered the public domain in the past 15 years. To address “how” elements, Pfizer suggests having general comments on good practice and then cross-referencing other more specific guidances for more detailed aspects.

Merck notes that FDA and drug developers have “gained a wealth of experience performing exposure-response analyses and leveraging the results to influence drug development and inform regulatory review. It expresses appreciation for the agency’s efforts to advance Model Informed Drug Development and to update its guidance to reflect recent advances in regulatory science.

It notes that the current guidance emphasizes ideas and principles but lacks specific examples of application. “It would be more helpful to sponsors if specific examples are included in the new guidance from across therapeutic areas to demonstrate how exposure-response analysis has been, or could be used to support regulatory decision-making,” the comment says.

Janssen’s response lists 11 points on which the company would like additional guidance in the revised document.

The International Consortium for Innovation and Quality in Pharmaceutical Development asks FDA to elaborate further on the importance of free exposure at the site-of-action, and how exposure in surrogate compartments such as plasma can be leveraged, and also on the importance of variability in exposure-response predictions.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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