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Description

It is responsible for detoxifying chemicals, fighting free radicals, and preventing disease

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In addition, a new statement has been added, which clarifies that non-clinical methods can be used to support a conclusion that the proposed generic peptide (recombinantly, synthetically, or semi-synthetically produced) and the RLD can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. The agency said the recommendations outlined in these PSGs can also apply to the development of other generic peptide drug products

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