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Form FDA 2253 is the standard form Life Sciences companies need to fill out to start the regulatory review process for their promotional content. Along with all the promotional content associated with a submission, the form gathers the information the FDA needs to review advertisements and promotions all in one place.
Form 356h includes information such as applicant information, proposed indication, establishment information, and more. Sponsors submitting New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs) need to include Form 356h.
This form is officially known as the Application to Market a New or Abbreviated New Drug or Biologic for Human Use, and it is submitted to the U.S. Food and Drug Administration (FDA) as part of the regulatory process for gaining approval to market a new drug or biologic product.
To submit your voluntary report: Complete voluntary Form FDA 3500 online. Call 1-800-FDA-1088 to report by telephone.
As part of its review, FDA assesses the manufacturing process and the manufacturers strategy to control within-product variations. These control strategies are put in place to help ensure that manufacturers produce biological products with consistent clinical performance.
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