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CENTER FOR DRUG EVALUATION AND RESEARCH
Approval Package for:
APPLICATION NUMBER:
209570Orig1s000
Trade Name:Benznidazole tablets 100 mg and 12.5 generic or Proper
Name:benznidazoleSponsor:Chemo Research,
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To fill out a summary review for FDA, follow these steps:
02
Begin by gathering all the necessary information about the product or medication being reviewed.
03
Start the summary review by providing a brief introduction of the product and its purpose.
04
Include details about the clinical trials and studies conducted, such as the methodology, sample size, and results.
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Review the summary review for accuracy and completeness before submitting it to the FDA.
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Follow any specific formatting or documentation guidelines provided by the FDA.
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Submit the completed summary review to the FDA as per their submission process.
Who needs summary review - fda?
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What is summary review - fda?
Summary Review - FDA is a process for the review of certain types of medical devices by the Food and Drug Administration.
Who is required to file summary review - fda?
Manufacturers of medical devices seeking approval for marketing in the United States are required to file a Summary Review with the FDA.
How to fill out summary review - fda?
The Summary Review form can be filled out electronically through the FDA's online portal or submitted via mail with the required documentation.
What is the purpose of summary review - fda?
The purpose of Summary Review - FDA is to provide a streamlined review process for certain medical devices, expediting their approval for marketing in the US.
What information must be reported on summary review - fda?
The Summary Review must include information about the device, its intended use, safety and effectiveness data, labeling, and any other relevant information.
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