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What were two major amendments introduced as part of bpca

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Reference no: EM131218929

Biology Assignment

Go to:

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

6-Go to: https://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.

Reference no: EM131218929

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