Click on the “Drugs” tab.

1. Go to http://www.fda.gov/
2. Click on the “Drugs” tab.
3. Find box on “Approvals and Clearances”. Click on “Search Drug Approvals by Month Using Drugs@FDA”. That should bring you to the “Drug Approval Reports”.
4. Choose “Original New Drug Approvals (NDAs and BLAs) by Month”.
5. Select your month of birth and year 2015. Click “Submit”.  Write your birth month across your name on your report.( my birth day is March 14,)
6. From the resulting table, choose one of the drugs approved during your birth month that has a review classification entry in the 4^th column to describe in detail. In your report, mention your drug name, the NDA or BLA Application number, active ingredient, NDA chemical type (state the meaning of the number- you’ll find the meaning below the table), and review classification (if available). Spell out and describe what the review classification means.
7. Click on the entry in the first column “Drug name and FDA Appln #” for your chosen drug. That will bring you to the “Drug Details”
8. Click on “label information”.
9. In the upper box, click on “View the label approved on date” file (PDF). What is the title of the resulting document?
10. For what indication is the drug for?
11. Mention at least one warning and adverse reaction on the use of each drug. Define/describe any uncommon medical or scientific word that you use.
12. List and briefly describe other types of information that are in the label.
13. Now go to http://clinicaltrials.gov/
14. In the search box, type the active ingredient of your drug, then click “search”.
15. Under the “List” tab, click on “Show display options”
16. Check the “phase” box. Click “Update display”
17. Click on one of the phase 3 studies that has a status of “Completed”. It is possible that your drug was approved after only a phase 2 in which case you will be looking at Phase 2 details.  Or if there is no completed phase 3, go with a phase 3 that is still “Recruiting”.
18. Mention at least 2 patient inclusion and 2 exclusion criteria. Use google to explain technical terms that you may encounter as inclusion/exclusion criteria.
19. Do a Pubmed search on the drug or indication and add other interesting tidbits. Just pick 1 really good paper to summarize. Follow the correct reference citation format.

 

1 page, Arial 11 pts, 1.15 spacing, essay format.