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
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The FDA raised data integrity concerns at Synapse and downgraded generic drug products that used data from the CRO.
In a 17 June letter, the agency said it has “significant concerns” about the bioequivalence and bioavailability studies conducted...
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