Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2592799 | Regulatory Toxicology and Pharmacology | 2009 | 7 Pages |
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.
Keywords
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Authors
Lesley M. Reeve,