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

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