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CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 208984Orig1s000 022128Orig1s017 Trade Name:SELZENTRYGeneric or Proper Name:maravirocSponsor:Vii Healthcare CompanyApproval
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How to fill out fda approves expanded use
How to fill out fda approves expanded use
01
To fill out FDA approves expanded use, follow these steps:
02
Gather all necessary information and data related to the expanded use you are seeking approval for.
03
Review the FDA guidelines and requirements for submitting an application for expanded use.
04
Prepare a comprehensive and detailed submission package, including a cover letter, supporting documents, and any relevant clinical trial data or studies.
05
Complete and submit the appropriate FDA application form, such as Form FDA 1571 for a new drug application or Form FDA 3674 for a supplemental application.
06
Pay the applicable fees for the submission, as per the FDA fee schedule.
07
Submit the application package electronically through the FDA's Electronic Submissions Gateway (ESG) or mail a hard copy to the appropriate FDA division or office.
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Await feedback and potential requests for additional information from the FDA.
09
Respond promptly to any FDA inquiries and provide any requested additional information or clarification.
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Cooperate with the FDA during the review process, including participating in any necessary meetings or evaluations.
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Monitor the status of your application through the FDA's online tracking system and be prepared to address any further inquiries or requests from the FDA.
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Once the FDA approves the expanded use, ensure compliance with any post-approval requirements and regulations.
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Various stakeholders and individuals may need FDA approves expanded use, including:
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- Insurance companies and healthcare payers assessing the cost-effectiveness and coverage of expanded use treatments
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- Public health organizations and policymakers considering the potential benefits and risks of expanded use
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What is fda approves expanded use?
FDA approves expanded use when a drug or medical device is approved for a new indication or patient population.
Who is required to file fda approves expanded use?
The manufacturer or sponsor of the drug or medical device is required to file for FDA approval of the expanded use.
How to fill out fda approves expanded use?
The manufacturer or sponsor must submit a supplemental application to the FDA with data supporting the expanded use.
What is the purpose of fda approves expanded use?
The purpose is to ensure that the drug or medical device is safe and effective for the new indication or patient population.
What information must be reported on fda approves expanded use?
The application must include clinical trial data, safety information, and proposed labeling changes.
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