STAT+: European regulator will review study data from contract research organization due to ‘serious concerns’
The move comes after Spanish regulators raised “serious concerns about the validity and reliability” of data generated Synapse Labs.
In the latest melee over the safety of prescription medicines, the European Medicines Agency is reviewing studies conducted by Synapse Labs, a contract research organization, due to questions about its study data.
The review comes in response to an inspection of Synapse facilities by Spanish regulators, who raised “serious concerns about the validity and reliability” of clinical trial data generated by the company. An EMA spokesman explained this type of referral is triggered following concerns about quality, safety or effectiveness of generic medicines that were approved based on the data.
In its statement, the EMA said it will “assess the impact on the benefits and risks of medicines that were authorized on the basis of studies performed at Synapse Labs’ facilities.” The agency will also look at the “impact on medicines currently being evaluated for authorization that use study data generated by the company.” The review will help the EMA decide whether any action is needed to protect public health.
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