Article ID Journal Published Year Pages File Type
2592799 Regulatory Toxicology and Pharmacology 2009 7 Pages PDF
Abstract
Conclusion. Some increases in non-clinical PMCs were attributed to increased non-clinical data requirements from the Regulators. However, strategic deferrals by the Applicant, unintended omissions due to poor regulatory intelligence and overall differences in risk perception between Regulators and Applicants account for a significant proportion of the non-clinical PMCs.
Related Topics
Life Sciences Environmental Science Health, Toxicology and Mutagenesis
Authors
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