How long does the FDA require retention of investigational drug study records?

The requirement from the FDA regarding the retention of investigational drug study records is that they must be kept for at least two years after the investigational drug has been approved by the FDA. This period is crucial as it allows the FDA and other regulatory bodies to access the data for any necessary reviews or audits related to the study's integrity and safety outcomes.

Retention of records for this duration ensures that researchers and sponsors can provide any supporting documentation if questions arise regarding clinical trials or the drug's safety and efficacy post-approval. This policy reflects the importance the FDA places on maintaining a thorough historical record of clinical data, which can aid in ongoing monitoring and evaluation even after a drug has received approval.

The requirements for retention periods shorter than this don’t align with FDA policies aimed at protecting public health and ensuring accountability in clinical research.