Food and Drug Administration Coursework Assignment

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Web Field Trip

 

For this assignment, you will visit various websites to learn more about the FDA and then answer the questions below for each trip to provide some information about what you learned on each trip.

 

 

Trip #1

 

Review the following websites (some links on the site may have their own additional links to explore) and one of the links is to a training video:

 

• Milestones in U.S. Food and Drug Law History

www.fda.gov/opacom/backgrounders/miles.html

 

• Drug Review and Related Activities in the United States video

www.connectlive.com/events/drugdev/viewvideos.html#

 

• New Drug Development Process-

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm

 

• Investigational New Drug (IND) Review Process-

http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm

 

 

• New Drug Application (NDA) Review Process-

http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/newdrugapplicationnda/default.htm

 

 

In a paragraph or two, explain what you learned about the history and development of drug and medical product regulation and the FDA and include in your explanation something you found interesting.

 

Also explain what you learned about the new drug development and approval process.

 

 

Trip #2

 

Review the following websites (some links on the site may have their own additional links to explore):

 

• Post-Marketing Surveillance

http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/ucm090385.htm

 

 

• Prescription Drug Advertising and Promotional Labeling

http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090308.htm

 

http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/drugmarketingadvertisingandcommunications/ucm209384.htm

 

Explain in a paragraph or two what you learned about CDER’s post-approval activities.

Trip #3

 

Go to this website:

 

• DER Prescription drug approvals

www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

 

The site provides an alphabetical index of approved prescription drugs. Find a drug that has been approved and click on the links on the page about the drug to review the approval history and the label for the drug.

 

Note you will have to find a drug with the label information available online to answer this question (there are some approved drugs on the site where the label info is not online).

 

Review the information in the label for possible side-effects or adverse reactions. Do you think the label provides an adequate warning for physicians or consumer so that they will be aware of potential dangers of the drug? Explain why or why not.

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