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EU Takes Action To Prevent Further Impurities After Sartans

 
• By Dave Wallace

The EMA is launching an initiative aimed at preventing impurities in medicines and better handling cases where impurities do occur, following the agency’s experiences in dealing with sartans that contained nitrosamine impurities.

Prevention
The EMA is taking action to prevent impurities in medicines • Source: Shutterstock

The European Medicines Agency is launching an initiative involving a range of European regulatory actors that the EMA says is aimed at preventing incidents similar to last year’s discovery of nitrosamine impurities in sartan medicines, as well as improving the management of such incidents when they do occur.

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Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
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Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
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OGD’s Policy Office Cut To Have ‘Profound’ Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

 
• By Urtė Fultinavičiūtė

The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.

More from Policy & Regulation

OGD’s Policy Office Cut To Have ‘Profound’ Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

 
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The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.

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Generics Bulletin reviews global regulatory developments across the world.