What are the expectations for the ind submission content

Reference no: EM133515515

Assignment:

The paper will follow a particular disease state Rheumatoid arthritis and product oral drug baricitinib, over the course of its development from pre-clinical to clinical, and post-market.

Using the guidance "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry", use the template/required sections for a pre-NDA meeting and make a pre-NDA meeting request and package.

Remember the questions from the pre-IND meeting and agreements made. Incorporate into the pre-NDA as appropriate:

Background: Provide an overview of the development history of baricitinib for rheumatoid arthritis.

Clinical/regulatory

Question 1: What are the recommended primary and secondary endpoints for the Phase 3 trial?

Question 2: Are there any specific safety monitoring requirements during the trial?

Question 3: What are the expectations for the IND submission content and format?

Clinical/safety

Question 4: Are there any safety concerns or precautions that should be considered during the trial?

Clinical pharmacology

Question 5: What pharmacokinetic and pharmacodynamic data are required for the IND submission?

Question 6: Are there any special considerations for drug-drug interactions?

Nonclinical

Question 7: What nonclinical data should be included in the IND submission?

Reference no: EM133515515

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