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November 18, 2008, Steve E. Through, M.D., MPA Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services 7500 Security Blvd. Baltimore, MD 212441850 Louis B. Jacques, M.D. Division
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What is ncd request for submission?
NCD request for submission is a formal request for the submission of a new drug application to the regulatory authority for approval.
Who is required to file ncd request for submission?
The pharmaceutical company or sponsor developing the new drug is required to file the NCD request for submission.
How to fill out ncd request for submission?
To fill out the NCD request for submission, the company must provide detailed information about the new drug, its development process, clinical trials, and safety data.
What is the purpose of ncd request for submission?
The purpose of NCD request for submission is to seek approval from the regulatory authority to market and sell the new drug.
What information must be reported on ncd request for submission?
The NCD request for submission must include information on the drug's chemical composition, manufacturing process, pharmacology, preclinical and clinical studies, and safety profile.
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