Get Summary For Basis Of Approval - Bcg Vaccine Pdf - 1mb - Fda

This guide provides a clear and comprehensive overview of how to fill out the Summary For Basis Of Approval - BCG Vaccine PDF, ensuring users can complete the process accurately and efficiently. Follow the step-by-step instructions to navigate each section of the form effectively.

Follow the steps to successfully complete the Summary For Basis Of Approval form.

1. Press the ‘Get Form’ button to access the PDF document. This will allow you to download or open the form for online completion.
2. Locate the reference number field and enter '92-0308'. This is essential for the identification of your submission.
3. In the trade name section, type 'TICE@ BCG'. This is the name under which the vaccine is marketed.
4. Fill in the generic name by entering 'BCG LIVE'. This denotes the generic formulation of the vaccine.
5. In the manufacturer section, input 'Organon Teknika Corporation' along with the address '100 Akzo Avenue, Durham, NC 27112'.
6. Specify the date of approval as 'August 4, 1998'. This date is crucial for the record of when the vaccine received approval.
7. In the indications and usage section, provide the appropriate clinical uses. Clearly list the conditions for which the BCG vaccine is indicated, including the treatment details.
8. Complete the dosage form, route of administration, and important instructions on how to prepare and administer the vaccine.
9. Provide any relevant data regarding manufacturing and controls, ensuring to include detailed specifications if applicable.
10. Upon completion of the form, save your changes, and ensure to download or print the document for your records. You may also choose to share it with relevant parties as necessary.

Ensure all essential documents are completed accurately. Begin filing the Summary For Basis Of Approval today to streamline your process.