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New FDA Forms for INDs, NDAs, and BLAs: What to Know Before Submitting By DocShifter 5 minutes read All clinical trial or marketing applications submitted to the FDA must include a form that summarizes the content of the submission and any relevant information on the sponsor and drug for the reviewers
It does not raise creatinine and does not cause kidney stones
If the advisory panel votes against reclassification, or if a future administration revisits the question, these compounds could return to Category 2 restriction
2 Sun, Xiaojin, et al
