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CENTER FOR DRUG EVALUATION AND
RESEARCHAPPLICATION NUMBER:205641Orig1s000
CLINICAL PHARMACOLOGY AND
BIOPHARMACEUTICS REVIEW(S)OFFICE OF CLINICAL PHARMACOLOGY:
CLINICAL PHARMACOLOGY REVIEW
NDA205641Submission
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What is office of clinical pharmacology?
The Office of Clinical Pharmacology is a division within the U.S. Food and Drug Administration (FDA) responsible for overseeing the clinical pharmacology aspects of drug development.
Who is required to file office of clinical pharmacology?
Drug sponsors are required to file information with the Office of Clinical Pharmacology as part of the drug development process.
How to fill out office of clinical pharmacology?
To fill out the Office of Clinical Pharmacology forms, drug sponsors must provide detailed information about the pharmacokinetics, pharmacodynamics, and other relevant clinical aspects of their drug.
What is the purpose of office of clinical pharmacology?
The purpose of the Office of Clinical Pharmacology is to ensure that drugs are safe and effective for use by the general public.
What information must be reported on office of clinical pharmacology?
Drug sponsors must report detailed information about the clinical pharmacology aspects of their drug, including data from clinical trials and other relevant studies.
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