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CY 2017 CDR Breakthrough Therapy Calendar Year Approvals Data as of September 30, 2017, Submission Type and NumberProprietary Name BLA 125554SUPPLEMENT24OPDIVONIVOLUMABBRISTOLMYERS SQUIBB COMPANY
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What is cy cder breakthrough formrapy?
Cy CDER breakthrough therapy is a designation by the FDA for certain drugs that show promising potential in treating serious or life-threatening conditions.
Who is required to file cy cder breakthrough formrapy?
Drug manufacturers or sponsors who have a drug that meets the criteria for breakthrough therapy designation are required to file for cy CDER breakthrough therapy.
How to fill out cy cder breakthrough formrapy?
To fill out the cy CDER breakthrough therapy form, manufacturers or sponsors need to provide detailed information about the drug, the condition it is intended to treat, and any clinical data supporting its efficacy.
What is the purpose of cy cder breakthrough formrapy?
The purpose of cy CDER breakthrough therapy is to expedite the development and review of drugs that show significant potential in treating serious illnesses.
What information must be reported on cy cder breakthrough formrapy?
Information such as the drug's mechanism of action, clinical trial data, safety profile, and proposed labeling must be reported on the cy CDER breakthrough therapy form.
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