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In the interim, continued shared decision making with patients and clinical vigilance for pancreatic diseases in patients on GLP-1RA therapy remains prudent

"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

Initial improvements tend to appear within 5 to 10 days of consistent administration

It is not a drug, dietary supplement, food additive, cosmetic, or therapeutic agent, and must not be used in or on humans or animals