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Guidance for industry: Immunogenicity assessment for therapeutic protein products

Again, it could change over time

8:30 - From "Supports" to "Improves": Strengthening Claims Katie discusses how her research evaluation allowed Kyowa to strengthen certain claims, changing language from "supports focus and attention" to " improves focus and attention" based on the totality of evidence from existing studies

LJP, Lonicera japonica polysaccharides

"While we acknowledge your response that an abrupt shortening of the enrollment period led to challenges and mistakes, your response is inadequate because, regardless of the length of the enrollment period, you are still responsible for ensuring that subjects meet protocol-specified eligibility criteria before you enroll them into the study," said FDA