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US FDA Deems Synapse’s Clinical Trials ‘Unacceptable’

 
• By Urtė Fultinavičiūtė

The FDA followed the EMA’s lead and declared Synapse’s trials “unacceptable” forcing drug firms that used CRO’s services to repeat studies to regain therapeutic equivalence ratings.

One line illustration of hangs gestures indicating dispute or disapproval
The FDA downgraded several products to a BX rating after raising data integrity concerns at a CRO. • Source: Shutterstock

Generic drug sponsors who used the contract research organization Synapse may have to repeat bioequivalence trials after the US Food and Drug Administration raised data integrity concerns and determined studies conducted by the firm are not acceptable.

Key Takeaways

  • The FDA raised data integrity concerns at Synapse and downgraded generic drug products that used data from the CRO.

  • Sponsors must redo bioequivalence studies...

In a 17 June letter, the agency said it has “significant concerns” about the bioequivalence and bioavailability studies conducted by the CRO and concluded that the firm has “created...

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