Get Fda 2252 Form

The Fda 2252 Form is essential for submitting annual reports for drugs and biologics intended for human use. This comprehensive guide will assist you in completing the form online with ease and efficiency.

Follow the steps to fill out the Fda 2252 Form online.

1. Press the ‘Get Form’ button to access the form and open it in your online editing tool.
2. Begin by filling in the application type and application number as required in the designated fields.
3. Provide your contact information, including the name of the applicants and their phone number.
4. Select the type of report by checking the appropriate box for either annual or other reports.
5. Enter the name of the drug or biologic in the corresponding section.
6. If applicable, list all other NDA or BLA numbers in the appropriate field.
7. Indicate the time frame covered by the report, specifying the start and end dates in the month and year format.
8. Identify the contents of the report by entering information for each section, including summary of new information, distribution data, and any changes related to chemistry and manufacturing.
9. Complete the section for type of information and include any annual progress reports of postmarketing studies if necessary.
10. Type the name and title of the responsible official or agent and ensure a signature is provided if required.
11. Fill in the applicant’s return address accurately, including the name of the sponsor, address line, city, state, and zip code.
12. Once all necessary fields are complete, save your changes, and proceed to download, print, or share the form.

Start filling out the Fda 2252 Form online today to ensure compliance with reporting requirements.