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EU Preparing Guidance On Synthetic Oligonucleotides & Peptides

 
• By Ian Schofield

Two new quality guidelines are needed to address the increase in applications for clinical trials and marketing authorizations of oligonucleotide- and peptide-based medicines, says the EU regulator.

Antisense oligonucleotides can be used for chronic conditions such as cancer • Source: Shutterstock

The European Medicines Agency is preparing new EU guidance for companies and regulators on the development and manufacture of synthetic oligonucleotides and synthetic peptides for use as medicines.

Guidance is needed because the number of clinical trial and marketing authorization applications for each kind of product has increased...

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