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.”
You may also be interested in...
Generic Drugs Outlined As ‘Significant Public Health Priority’ For FDA
The FDA Office of Generic Drugs has published its annual report, highlighting its contributions to the approval of Viatris’ generic cyclosporine rival to Restasis, alongside updates to bioequivalence standards and support for competition.
Strides Founder Back As MD, Asserts Confidence In US As Company Exits Parts Of Europe
Back as Strides managing director, founder Arun Kumar is confident of reversing a slide in profits via a recalibration strategy that saw the company exit Canada and a few European markets. Meanwhile, eyes are on the fallout of a CRO that serviced Strides apart from Sandoz, Teva and more getting caught in CHMP and FDA’s crosshairs.
Panexcell EU Marketing Authorizations At Risk Over Unreliable Data
The EMA’s CHMP has recommended suspending all marketing authorizations for generics tested by Panexcell Clinical Laboratories at its site in Mumbai over inadequate data. To lift the suspension, companies relying on data from Panexcell must provide alternative data demonstrating bioequivalence.