Spring Intro 2023

03/03/2023

Section 5.3 - nonclinical Safety Data

N.B. Some excipients have relevant nonclinical safety data. These should be included in section 5.3 and not in Section 6.1 (List of Excipients).

Environmental Toxicity data need to be included in Section 5.3 if data suggest a potential risk to environment. Otherwise add to section 6.6

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Clinical Trials

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