1. What is an ANDA (Abbreviated New Drug Application), and when is it used in the pharmaceutical industry?
2. Describe the key components of an ANDA submission.
3. How do you ensure the bioequivalence of a generic drug in an ANDA?
4. What are the major differences between an NDA (New Drug Application) and an ANDA?
5. What is eCTD (electronic Common Technical Document), and why is it essential for regulatory submissions?
6. Can you explain the advantages of using eCTD over traditional paper-based submissions?
7. How do you handle electronic validation and submission errors in eCTD?
8. Discuss the main modules of an eCTD submission and their significance.
9. How does eCTD improve the efficiency and review process for regulatory authorities?
10. Describe the key challenges and best practices in implementing eCTD submissions.
11. What are the regulatory requirements for post-approval changes in an ANDA submission?
12. How do you manage variations and amendments to an approved ANDA?
13. Explain the significance of stability studies in the context of ANDA submissions.
14. What is GDUFA? What is current Fee structure for ANDA? Explain it significance in context of ANDA.
15. Describe the FDA’s current approach to prioritizing ANDA reviews.
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