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Regulators Encourage Science And Risk-Based Approaches In NDAs For Peptides And Oligonucleotides

 
• By Joanne S. Eglovitch

Regulators in the US and the EU urged manufacturers to follow the general principles set in International Conference on Harmonization guidelines in developing new oligonucleotides and peptide drugs. They say that in the absence of tailored guidance, sponsors should take a science- and risk-based approach in developing these products, which have flooded the development pipeline.

Liraglutide, a long-acting glucagon-like peptide-1 receptor agonist. An injectable drug for the treatment of type 2 diabetes. 3d structure.

Regulators in the US and the EU urged manufacturers to follow the general principles set in International Conference on Harmonization guidelines in developing new oligonucleotide and peptide drugs. They said that in the absence of tailored guidance, sponsors should take a science- and risk-based approach in developing these products.

Speakers noted at a recent industry meeting that oligonucleotides and peptides are intermediate in size and complexity relative to small...

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