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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration For a Business Headquartered Outside the United States 1. Name of business requesting MD UFA Small Business status FY 2013 MD UFA
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Fill in your personal information accurately. This includes your name, address, and contact details. Make sure to double-check for any errors or typos.
03
Provide specific details about the product or facility you are reporting. This may include the name, address, and contact information of the facility, as well as a description of the product.
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Who needs form FDA 3602:
01
Manufacturers, packers, and distributors of FDA regulated products may need to fill out form FDA 3602.
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This form is used to report any suspected product tampering, contamination, or other incidents that may pose a risk to public health.
03
It is important to promptly fill out this form and submit it to the FDA to ensure the safety and integrity of regulated products in the market.
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What is form fda 3602?
Form FDA 3602 is a document used for the evaluation of products that may qualify for expedited review or special programs, such as breakthrough therapy designation or priority review.
Who is required to file form fda 3602?
Sponsors of drug products who are seeking to apply for expedited program designations from the FDA are required to file Form FDA 3602.
How to fill out form fda 3602?
To fill out Form FDA 3602, applicants need to provide detailed information about the drug product, its indications, patient population, and data supporting the request for expedited review.
What is the purpose of form fda 3602?
The purpose of Form FDA 3602 is to facilitate the FDA's evaluation of products for special programs intended to speed up the availability of important medications.
What information must be reported on form fda 3602?
The information that must be reported includes the product name, the indication for use, the supporting evidence for the expedited designation, and detailed information about the potential patient population.
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