FDA Issues Draft Guidance on Drug Development Strategies

The FDA recently issued draft guidance entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” which provides enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics 21 license applications (BLAs).  The draft guidance suggests how drug companies can more effective in selecting patients in which detection of a drug effect is more likely than it would be in an unselected population.  The enrichment strategies were broken down into three broad categories:

  • Strategies to decrease heterogeneity
  • Prognostic enrichment strategies
  • Predictive enrichment strategies

The guidance further provides suggestions as to how companies can boost the speed and efficiency of clinical trials.
Comments and suggestions regarding the draft document are due within 60 days of publication in the Federal Register, which occurred in December 2012.

David Katz is a Senior Audit Manager providing domestic and international accounting, auditing and business consulting services to public and private clients in a variety of industries.

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