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Challenges for the FDA The Future of Drug Safety: Workshop Summary (2007) / Chapter Skim
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4 Integrating Pre- and Postmarket Review
Pages 26-31

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From page 26...
... Recommendation 4.13 The committee recommends that the CDER review teams regularly and systematically analyze all postmarket study results and make public their assessment of the significance of the results with regard to the integration of risk and benefit information. Recommendation 5.4 The committee recommends that the FDA evaluate all new data on new molecular entities no longer than 5 years after approval.
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From page 27...
... OPERATIONAL CHALLENGES TO INITIATING A LIFE-CYCLE APPROACH TO DRUG REVIEW1 Dr. Tilson identified and discussed four major sets of operational challenges to the implementation of a life-cycle approach to drug review: • Methodological challenges -- Knowledge of product safety does not readily build over time and in a linear fashion; rather, gaining such knowledge is a complex and nuanced process.
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From page 28...
... . The FDA's initiatives are geared toward effectively integrating the pre- and postmarket review programs, as well as strategically monitoring drugs throughout their life cycle so as to be able to determine their benefit–risk balance more accurately and relay that information to the public.
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From page 29...
... Dr. Temple expressed enthusiasm for the safety focus initiative in particular, partly because there is already a model for how it might work: the Division of Neuropharmacology, now the Division of Neurologic and Psychiatric Drug Products, has a safety group comprising about half a dozen clinical reviewers, most with epidemiological training, playing a role in both pre- and postapproval drug evaluation.
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From page 30...
... He chose to highlight an initiative that began in March 2005 -- a postmarketing "Process Improvement Team." The goal was to identify best practices for improving safety processes that span the postmarket activities of OND and OSE so the two offices can better carry out their respective missions and enhance CDER's responsiveness to postmarket safety issues. The team formulated three key policy concepts: (1)
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From page 31...
... In response to Recommendation 5.4 (evaluation of all data on NMEs within 5 years following approval) , the FDA initiated a pilot program to examine whether a periodic review of all data at 18 months postapproval can adequately identify potential safety issues and whether more frequent reviews are needed.
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Key Terms

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  • benefit information

  • adverse event
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  • electronic postmarket
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  • drug application

  • postapproval regulatory
  • drug evaluation
  • cder review
  • postapproval benefit
  • timely review

  • safety tracking
  • focus initiative
  • minimization action
  • molecular entities
  • action plans

  • joint authority
  • randomized controlled
  • fda plans
  • ose staff
  • formal written

  • premarket data
  • risk minimization
  • review postmarket
  • postmarket drug
  • psychiatric drug


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