FDA Says Studies By Panexcell And Synchron “Unacceptable”

US Agency Warns Pharmaceutical Companies Against Using Firms’ Data

The US FDA has objected to studies conducted by India-based contract research organizations Panexcell Clinical Lab and Synchron Research Services, because of data integrity concerns. The FDA has warned pharmaceutical companies sponsoring drug application approvals, that data generated by Panexcell and Synchron will be “unacceptable.” 

lab
After conducting inspections at the facilities of Panexcell and Synchron, FDA finds data integrity issues • Source: Alamy

More from Regulation

More from Policy & Regulation