Get Bla Checklist

Filling out the Bla Checklist online is an important step in submitting a Biologic License Application (BLA) to the FDA. This process requires careful attention to detail and compliance with specific regulations. This guide will help you navigate each section of the checklist effectively.

Follow the steps to fill out the Bla Checklist accurately.

1. Click ‘Get Form’ button to obtain the Bla Checklist and open it in your preferred document viewer.
2. Review the safety, purity, and potency requirements. Prepare documentation demonstrating that your product is safe, pure, and potent, including all relevant laboratory test results.
3. Determine the appropriate division of the FDA for your application. Identify whether to submit to the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER) based on the type of biologic.
4. Prepare the archival and review copies of the BLA. Ensure that the archival copy is bound in a blue cover jacket and includes a cover letter with important application details.
5. Complete application Form FDA 356h, ensuring it is signed by the applicant or an authorized agent, and include any necessary patent information.
6. Create an index for your application that identifies all elements and their corresponding volume and page numbers.
7. Draft a summary of the application, typically between 50 to 200 pages. This should include essential safety and effectiveness data along with proposed labeling.
8. Fill out the Chemistry, Manufacturing, and Controls section, detailing information about both the drug substance and final drug product.
9. Describe the establishment, including a floor diagram and information about contamination controls.
10. Submit clinical data that outlines findings from studies and includes a statistical section to evaluate the clinical data.
11. Review and compile all additional required sections, including labeling information and any necessary documentation regarding patent information.
12. After completing the checklist and ensuring all documents are prepared, save changes, and finalize your application for submission.

Begin filling out your Bla Checklist online today to ensure your BLA submission is complete and compliant.