Newsletter - January 13, 2022
Investigator Gets FDA Warning Letter for Not Retaining Trial Documents
A clinical investigator received a Warning Letter for not retaining the clinical trial records after the completion of the trial in a rare such letters issued by the FDA. This is an example of the systematic failure not only of the investigator but also the CRO and the sponsor who all share responsibility to maintain clinical trial documentation...Read More
FDA Provides Guidance on Histopathology Review for Non-clinical Studies
A detailed histopathology is usually a critical part of a non-clinical toxicology study as it can indicate risk not obvious from observations of physical symptoms and could be used to evaluate long-term risk of an investigational product (IP). Often the study pathologist reviewing the data might need an independent assessment of abnormal findings to...Read More
Investigator Gets FDA Warning Letter for Not Retaining Trial Documents
A clinical investigator received a Warning Letter for not retaining the clinical trial records after the completion of the trial in a rare such letters issued by the FDA. This is an example of the systematic failure not only of the investigator but also the CRO and the sponsor who all share responsibility to maintain clinical trial documentation...Read More
FDA Provides Guidance on Histopathology Review for Non-clinical Studies
A detailed histopathology is usually a critical part of a non-clinical toxicology study as it can indicate risk not obvious from observations of physical symptoms and could be used to evaluate long-term risk of an investigational product (IP). Often the study pathologist reviewing the data might need an independent assessment of abnormal findings to...Read More
