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Doc which was sent via email from June Germain on January 3 2012. OPDP s comments on the proposed IFU are based on the susbstantially complete version of the IFU titled NDA 22572 Kit Dec 6 2011. Regulatory Review Officer Division of Professional Promotion DPP Subject NDA 22572 MitosolTM for solution As requested in your consult dated August 24 2011 the Office of Prescription Drug Promotion OPDP has reviewed the proposed draft labeling for Mitosol TM for solution. 21 CFR 314. 50 i 3 Statement...
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What is 022572orig1s000 - fda?
022572orig1s000 - fda is a form required by the FDA for certain drug submissions.
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Drug manufacturers submitting new drug applications are required to file 022572orig1s000 - fda.
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To fill out 022572orig1s000 - fda, manufacturers must provide detailed information about the new drug being submitted for approval.
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The purpose of 022572orig1s000 - fda is to ensure that new drugs being submitted for approval meet safety and efficacy standards.
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Information such as drug ingredients, manufacturing process, clinical trial data, and labeling must be reported on 022572orig1s000 - fda.
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