Warning Letter — Naseem A. Jaffrani, M.D.
The FDA issued a warning letter to clinical investigator Naseem A. Jaffrani, M.D., following an inspection by the Center for Drug Evaluation and Research (CDER). The source indicates non-compliance in the conduct of clinical investigations, though it provides limited specific deal on the exact nature of the violations.
This notification primarily affects clinical investigators, site management organizations, and drug sponsors responsible for oversight of clinical trials. It specifically concerns professionals involved in GCP compliance and clinical site monitoring.
The issuance of a Warning Letter by CDER suggests significant deviations from Good Clinical Practice (GCP) or protocol requirements. Regulatory teams should interpret this as a signal that the FDA continues to prioritize investigator oversight and data integrity. Failure to address these findings could lead to disqualification of the investigator or the rejection of clinical data in support of drug applications.
Clinical investigators should perform a comprehensive review of study documentation for accuracy and completeness. Ensure site personnel are adequately trained on protocol adherence and that robust internal audit systems are in place to detect documentation gaps before agency inspection.
FDA Warning Letter issued to: Naseem A. Jaffrani, M.D.. 05/04/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/naseem-jaffrani-md-729750-05042026
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