Originally Published MD&DI July 2008
REGULATORY OUTLOOK
Top 10 Errors in Preclinical Testing Submissions
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- Poor or uninformed choices of appropriate test models (bench and animal).
- Insufficient proofreading of documents to be submitted.
- Inadequate risk analysis.
- Inadequately defined intended use and indications.
- Poor study design.
- Failure to properly identify standards, guidance documents, and precedents.
- Lack of justification of test acceptance criteria.
- Failure to submit raw data for all preclinical testing included in submission.
- Vague descriptions of test methodology.
- Inadequate presentation of test reports for FDA audience.
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