title: Utility and importance of animal data in drug product labels.
abstract: Information on the use and safety of medicines to assist prescription by healthcare professionals occurs in drug labels (Summary of Product Characteristics in Europe and Package Insert in the USA). Animal data (notably genotoxicity, reproduction toxicity and carcinogenicity and/or repeat dose toxicity testing) comprise an important component of the information (having a vital role in giving assurance that an extensive safety assessment for the medicinal product has occurred) and regulatory guidance is available to help inform on its input into drug labels. However, an evaluation of animal data for the 27 new drugs approved in the USA in 2013 (and the same drugs if available in Europe) shows great variability in detail and level of information presented within and across regions and/or the possibility of confusion on interpretation of some of the presented animal study findings. It is concluded that it may be time to revisit what animal data are presented in drug product labels (although bearing in mind current regional regulatory guidance requirements), not only to allow within and across region consistency on information given but to present it in a way that fully assists healthcare professions when prescribing a medicine.
authors.affiliation: Regulatory Strategy, Covance Laboratories Ltd., Otley Road, Harrogate HG3 1PY, North Yorkshire, United Kingdom. Electronic address: paul.baldrick@covance.com.
authors.forename: Paul
authors.initials: P
authors.lastname: Baldrick
mesh_terms: D000818:Animals; D017277:Drug Approval; D004348:Drug Labeling / Q000592:standards*; D005060:Europe; D011356:Product Labeling / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
keywords: Animal data; Drug labels; Package Insert; Summary of product characteristics