Regulatory innovation in postmarketing risk assessment and management

J. A. Staffa, G. J. Dal Pan

Research output: Contribution to journalArticlepeer-review

18 Scopus citations


The contemporary science of drug safety seeks not only to identify the risks associated with the use of medicines but also to quantify these risks, identify their risk factors, and assess strategies to minimize them. It monitors the use of medicines in actual practice to understand how the medical care system interacts with the intrinsic pharmacologic properties of medicines to produce the observed effects. To the extent possible, these analyses use a population-based approach that at times requires creativity and innovation. The key to effective safety management of drugs in the postmarketing setting is the ability to access sufficient good-quality data, interpret the data appropriately, challenge old assumptions, and define best practices in contemporary drug safety approaches.

Original languageEnglish (US)
Pages (from-to)555-557
Number of pages3
JournalClinical Pharmacology and Therapeutics
Issue number3
StatePublished - Mar 2012
Externally publishedYes

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)


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