BBS Assignment #2

Module 5 contains information about the FDA’s post approval surveillance efforts. This assignment gives you a chance to explore these issues in more detail.

Step One:            Go to the FDA Post-Marketing Surveillance website: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm090385.htm

Step Two:            Pick one of the programs (FAERS, MedWatch, Marketing and Advertising, etc.), learn more about the program by clicking on its link on the webpage.

Then, describe the purpose of the program,  the requirements of the program, and how it fits within the FDA mission of keeping drugs and devices safe and effective.

Step Three:        Pick some information that was provided to the FDA under the program you chose.

Explain the information that was provided and what action, if any, the agency took, and what you think about the information that was provided  and the agency’s response to that information.

Step Four:          Go to the Drug Safety Communications page:

http://www.fda.gov/Drugs/DrugSafety/ucm199082.htm

See if there any communications based on the information you found in Step Three. If so, describe what the communications are and if you think the communications were sufficient to warn Doctors and Patients about the issue.

If there is not one related to the information you found in Step Three, just pick a communication and answer the same questions (what are the communications you picked, are they sufficient, etc.