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FDA Outlines Regulatory Science Needs for Drug Evaluations

Pills and drug bottles (


The Food and Drug Administration published its proposed needs for regulatory science in the agency’s Center for Drug Evaluation and Research (CDER), its main drug regulating division. The document is available for public review and comments, which close 60 days following the 21 July 2011 publication.

CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. The work of the center covers more than just medicines, however. Popular personal care items such as fluoride toothpaste, antiperspirants, dandruff shampoos, and sunscreens are all considered “drugs” by CDER.

FDA’s draft report, prepared by CDER’s Science Prioritization and Review Committee, developed a comprehensive list of potential regulatory science needs, which were later reviewed by the agency’s senior management. The committee and management then agreed on seven major categories of priorities:

– Improve access to post-market data sources and explore feasibility of their use in different types of analyses

– Improve risk assessment and management strategies to reinforce the safe use of drugs

– Evaluate the effectiveness and impact of different types of regulatory communications to the public and other stakeholders

– Evaluate the link among product quality attributes, manufacturing processes and product performance

– Develop and improve predictive models of safety and efficacy in humans

– Improve clinical trial design, analysis and conduct

– Enhance individualization of patient treatment

Computational infrastructure needs and data standards were topics that affected several topic areas, but CDER already has efforts underway to address this issue.

Read more: FDA Issues Draft Guidance on Diagnostic/Therapy Companions

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