• 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 links 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.

McCune briefly reviewed the drug regulatory review life cycle (Figure 2-1) and offered a number of examples of potential areas for Pillar 2 research across the drug life cycle (Table 2-1). CDER scientists are already working in many of these areas. For each of these areas, she said, there are numerous potential scientific studies that could be done. One of the primary challenges is prioritization of studies as they relate to the MCM initiative.

In closing, McCune said, CDER has a robust regulatory science program with significant expertise to support the research agenda of the MCM initiative, and CDER researchers and reviewers are eager to collaborate on efforts to advance the regulatory science needs of the initiative.


FIGURE 2-1 FDA regulatory review cycle.
NOTE: BLA, biologics license application; IND, investigational new drug application;NDA, new drug application.
SOURCE: Susan McCune. 2011. Presentation at IOM workshop; Advancing Regulatory Science for Medical Countermeasure Development.

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