FDA Drug Approval Checklist
How to use the calculator:
1. Review each section of the FDA drug approval process.
2. Check the boxes next to the steps you have completed.
3. Click the “Check Progress” button at the bottom of the form.
4. The progress bar will update to show your overall progress.
5. A text message will appear below the progress bar, indicating your completion percentage.
6. Continue checking boxes as you progress through the FDA drug approval process.
7. When all boxes are checked, you’ll see a congratulatory message indicating full completion.
Why use the calculator:
1. Track Progress: Easily visualize your advancement through the complex FDA drug approval process.
2. Stay Organized: Use the checklist as a comprehensive guide to ensure no steps are missed.
3. Motivate Your Team: Share progress with stakeholders to maintain momentum and focus.
4. Educational Tool: Learn about the key stages involved in bringing a new drug to market.
5. Planning Aid: Identify upcoming steps and allocate resources effectively.
6. Compliance Support: Ensure all necessary regulatory requirements are being addressed.
7. Time Management: Estimate the overall timeline based on completed and remaining steps.
8. Communication Tool: Use the progress percentage in reports and presentations to quickly convey status.
Nirdosh Jagota is Managing Partner at GRQ Biotech Advisors with 30+ years in the biotech industry. A former executive at Amgen, Genentech/Roche, Merck, and Pfizer, he has led >25 NDAs/BLAs/MAAs and hundreds of INDs across global regulatory, quality, and compliance.