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EMA Recommends Dozens Of Suspensions Over Flawed Synchron Studies

Generic Marketing Authorizations To Be Suspended Following Similar Criticism From US FDA

 
• By Dave Wallace

The European Medicines Agency's human medicines committee has recommended the suspension of marketing authorizations for around 100 generics after identifying “irregularities” in how bioequivalence studies were conducted by Synchron Research Services.

Suspended stamp notebook pen
Marketing authorizations linked to Synchron data will be suspended • Source: Shutterstock

Around 100 generic drugs are expected to see their European marketing authorizations suspended after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) identified irregularities in bioequivalence studies carried out by contract research organization (CRO) Synchron Research Services.

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