FDA EIR - Ghulam Mufti, MBBS, DM - August 09, 2019

An FDA pre-approval data validation inspection was conducted at the site of Clinical Investigator Ghulam Mufti, MBBS, DM, in London, United Kingdom, from August 5 to August 9, 2019. This high-priority inspection, initiated by CDER's Office of Scientific Investigations, focused on protocol ACE-536-MDS-001 for Celgene Corporation's Biologics License Application (BLA) 761136, evaluating Luspatercept for Myelodysplastic Syndromes. The inspection was conducted under the regulatory framework of CPGM 7348.811 for Clinical Investigators and Sponsor Investigators, governing clinical studies authorized under §505 of the Federal Food, Drug, and Cosmetic Act.

The review encompassed informed consent, randomization, test article management, subject records, screening, follow-up documentation, and adverse event reporting. The inspector confirmed sufficient records for all 13 subjects screened and 11 enrolled, observing no discrepancies between site data and endpoint or adverse event listings. Crucially, the inspection concluded without the issuance of an FDA Form 483, Inspectional Observations, indicating no major violations or issues were identified. While no immediate corrective actions were required from Dr. Mufti, he was informed that the final classification and any potential future actions would be determined by central authorities.