Notifications on Data Integrity
FDA is committed to protecting the health of the American public by holding approved products to high standards of quality, safety, and efficacy.
FDA assesses the integrity and reliability of efficacy and safety data used for brand and generic drug approvals. In cases where FDA identifies data integrity concerns across multiple studies that support brand and generic drug products, FDA takes appropriate steps to notify industry and the public.
It is critical that drug product sponsors and/or applicants understand that they are responsible for ensuring the integrity of their study data and that their studies comply with FDA regulations [See guidance for industry: 1) Data Integrity for In Vivo Bioavailability and Bioequivalence Studies (April 2024) and 2) E6(R3) Good Clinical Practice (September 2025)].
FDA has issued the following notifications on data integrity:
- Notification to Pharmaceutical Companies: Certain studies conducted by Raptim Research Pvt. Ltd. are unacceptable (March 28, 2025)
- Notification to Pharmaceutical Companies: Clinical and Bioanalytical Studies Conducted by Synapse Labs Pvt. Ltd. are Unacceptable (June 18, 2024)
- Notification to Pharmaceutical Companies: Clinical and Bioanalytical Studies Conducted by Panexcell Clinical Lab or Synchron Research Services Are Unacceptable (September 16, 2021)
- Notification to Pharmaceutical Companies: Clinical and Bioanalytical Studies Conducted by Semler Research Are Unacceptable (April 20, 2016)