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Participant Information Sheet and Informed Consent Form Study Title:A Randomized Controlled Study To Compare The Safety And Efficacy Of IPX203 With Immediate Release CarbidopaLevodopa In Parkinson's Disease
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AbbVie submits a new drug by completing the necessary forms and submitting all required documentation to the appropriate regulatory agencies for review and approval.
The pharmaceutical company AbbVie is required to file a new drug application with the regulatory agencies.
To fill out AbbVie's new drug submission, the company must provide detailed information about the drug's composition, safety, efficacy, and manufacturing process.
The purpose of AbbVie submitting a new drug is to seek regulatory approval to market and sell the drug for a specific medical condition or use.
Information that must be reported on AbbVie's new drug submission includes preclinical and clinical trial data, manufacturing information, labeling, and safety monitoring plans.
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