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TOTAL NUMBER OF REPORTS ATTACHED OR SUMMARIZED a. Lowest Report Number b. Highest Report Number HCFA or FDA Provided No. - Year Sequence No. For each report in the range of report numbers listed above attach a completed copy of Part 2 of this form or a photocopy of the completed MedWatch FDA Form 3500A for the event that was sent to FDA and/or the manufacturer. Gov FORM FDA 3419 3/16 PAGE 1 Continue on Page 2 if necessary PSC Graphics 301 443-1090 EF PART 2 - SUMMARY OF EVENT If photocopies...
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The purpose of FDA forms is to collect information about regulated products, activities, and facilities to ensure compliance with FDA regulations and to protect public health.
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The information required on FDA forms may vary depending on the specific form, but generally includes product details, manufacturing processes, labeling, and compliance with regulations.
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