Application: Divisions of the FDA

The FDA is a complex organization with an extremely wide scope of responsibilities, including drugs, biologics, and medical device safety and research. The agency also oversees the public safety of cosmetics, foods, radiation-emitting electronic products, and veterinary products.

The Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER) are the three divisions of the FDA that administer safety of medical products and clinical research studies in their respective specialty areas.

To prepare for this Application Assignment, visit the FDA Organization page at http://www.fda.gov/AboutFDA/CentersOffices/default.htm. Here you will find a link to each division of the FDA. Review each of three divisions of the FDA that has jurisdiction over medical products. Search each site for activities currently underway that are based on clinical research studies. An example would be the clinical trials involving the Gardasil? vaccine.

To complete this Application Assignment, write a 2- to 3-page paper concerning an activity currently underway by one of these organizations that is of interest to you. Potential topics could include recalls for drugs or devices based on clinical research findings, an agency review of adverse events for a drug or medical device, or an activity about a current health issue that is somewhat controversial in the public sector.

Submit your Application Assignment to the Dropbox by Day 6.

Your written assignments must follow APA guidelines. Be sure to support your work with specific citations from this week?s Learning Resources and additional scholarly sources as appropriate. Refer to the Pocket Guide to APA Style to ensure your in-text citations and reference list are correct.

Save your Application as a “.doc” or “.rtf” file with the filename “APP6+last name+your first initial.” For example, Sally Ride?s assignment filename would be “APP6RideS”. Use the Submit an Assignment link, choose the Week 6: Application basket, and then add your Application as an attachment.