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Specifically regarding product-related impurities or variants, the guidance states that manufacturers should justify for each new specified peptide-related impurity the ANDA applicant should provide justification for why such impurity does not affect the safety of the proposed generic synthetic peptide (including with respect to immunogenicity) and why it does not affect its effectiveness

In a continuing crackdown on the sale of bootleg GLP-1 weight loss drugs, Connecticut Attorney General William Tong this month sent cease-and-desist letters to weight loss spas in Avon, Brookfield, and Danbury

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