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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
IPQ Monthly Update – July 2021 in Review
The feature story in this issue explores the dialogue regulators and industry are having on the key CMC issues that are presenting themselves in the development and review of peptides and oligonucleotides and the approaches and expectations for addressing them. A central focus is the discussion that took place at the USP 2021 peptides/oligonucleotides workshop. The story’s four parts explore: ● recent CMC/regulatory challenges of oligonucleotide drugs ● comparability challenges in crossing over to generics, including insights from recent FDA research ● comparing peptide and oligonucleotide CMC issues, and ● starting material specifications for oligonucleotides.
