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18: Chemistry, manufacturing and controls issues cost Satsuma Pharmaceuticals as the FDA issued a Complete Response Letter for its nasal powder migraine drug, STS101, according to a Thursday press release by parent company Shin Nippon Biomedical Laboratories

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facilities, and publishes batch-specific COAs so researchers can confirm concentration and purity data before incorporating IGF-1 LR3 or any other compound into a study protocol

Regulatory Guidelines and Mitigation Strategies for the Immunogenicity of Peptide-Oligonucleotide Conjugates Regulatory expectations established by the FDA and EMA require a phase-appropriate, risk-based strategy for mitigating immunogenicity that integrates molecular de-immunization, chemical modification of the oligonucleotide backbone, and stringent control of critical quality attributes (CQAs)