Bio Hw 5

Go to:

http://bpca.nichd.nih.gov/about/index.cfm

1-Give some background on why the need for the BPCA came about

2-In BPCA of 2002, what were the 3 categories of BPCA activities that are related to pediatric drug development?

3-What were the two major amendments introduced as part of BPCA 2007? 

4-Summarize important points mentioned under “BPCA Prioritization Process” and the “Priority List” under that.

5-Include the important points about the BPCA and PREA mentioned at:

a.     http://blogs.fda.gov/fdavoice/index.php/2013/08/fda-takes-step-to-encourage-pediatric-drug-studies/

6-Go to: http://www.pediatrictrials.org/ptn-studies

7-Scroll down to “Completed Studies”.

8-Choose one study where there is an entry under the column “Clinicaltrials.gov”. Click on the ID number.

9-Name the drug and what condition it was tested for.  Say some more, purpose, etc.

10-Scroll down the trials page where you will find the “eligibility criteria”. State the ages that are eligible to participate in the trial.