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FDA Role & Key Regs for New Meds

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Flavio Guzmán
Flavio Guzmán
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Module 2 : The Role of the Food and Drug Administration and Key Regulations of New Prescribed Medications for Practitioners http://www.fda.gov/oc/history/historyoffda/section5.html
Module 2 – Objectives ,[object Object]
Scenario Background ,[object Object],[object Object]
Question 1 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Answer for Question 1 ,[object Object],[object Object],[object Object],[object Object],NEJM 2005; 353:969-72
Question 2 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Answer to Question 2 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],A&R 2006
Question 3 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Answer to question 3 ,[object Object],[object Object],[object Object],JAMA 249:13: 1743-5.
Question 4 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],PDUFA Fact Sheet. http://www.fda.gov/cder/pdufa/default.htm ; http://www.fda.gov/cder/pdufa/default.htm
Answer to Question 4 ,[object Object],[object Object],IOM Recommendations on Drug Safety. 355:1753-5
FDA Responsibilities for Approving & Monitoring Drugs ,[object Object],[object Object],[object Object],[object Object],[object Object],FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997. http://www.fda.gov/cder/guidance/105-115.htm#SEC.%20406
Question 5 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],JAMA, 1983;249:1743-1745
Answer Question 5 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],FDA Consum 2002; 36(1):11-7. Fed Regist 2004; 69(50):12162-4. Fed Regist 2005; 70:8379-81. DHHS, OIG, 2006. FDA’s Monitoring of Postmarketing Study Commitments (OEI-01-04-00390). Ganslaw LS. Drug Safety. New Legal/Regulatory Approaches, 2005:7-10.
Patient Scenario ,[object Object],[object Object],[object Object]
Question 6 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],NEJM 2005; 325:325-8
Answer to Question 6 ,[object Object],[object Object],[object Object],[object Object],Section 502 (n) of the FD&C Act, and Title 21 Code of Federal Regulations, section 202.1
Question 7 ,[object Object],[object Object],[object Object],[object Object],[object Object]
Answer to Question 7 ,[object Object],[object Object],[object Object]
Question 8 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Answers to Question 8 ,[object Object],[object Object],http://www.bos.frb.org/economic/nerr/rr2003/q1/toomuch.htm#sidebar . http://www.ucpress.edu/books/pages/10083/10083.ch08.html
Question 9 ,[object Object],[object Object],[object Object],[object Object],[object Object]
Answers to Question 9 ,[object Object],[object Object],[object Object],[object Object],http://www.bos.frb.org/economic/nerr/rr2003/q1/toomuch.htm#sidebar . http://www.ucpress.edu/books/pages/10083/10083.ch08.html
“ Me-Too” Drugs ,[object Object],[object Object],[object Object],[object Object],NEJM 2005; 353:969-72
Question 10 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Answer to Question 10 ,[object Object],[object Object],[object Object],[object Object]
Question 11 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Answer for Question 11 ,[object Object],[object Object],[object Object],[object Object],The FDA Modernization Act of 1997. http://www.fda.gov/opacom/backgrounders/modact.htm
 
Question 12 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],http://dailymed.nlm.nih.gov/dailymed/about.cfm. http://www.fda.gov/cder/drug/infopage/COX2/NSAIDmedguide.htm. http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm. http://www.nlm.nih.gov/medlineplus/medicines.html
Answer to Question 12 ,[object Object],[object Object]
Question 13 ,[object Object],[object Object],[object Object],[object Object],[object Object]
Answer to Question 13 ,[object Object],[object Object],[object Object],[object Object],http://www.fda.gov/medwatch/report/hcp.htm
Answer to Question 13 ,[object Object],[object Object],[object Object]

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FDA Role & Key Regs for New Meds

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  • 2. Module 2 : The Role of the Food and Drug Administration and Key Regulations of New Prescribed Medications for Practitioners http://www.fda.gov/oc/history/historyoffda/section5.html
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Editor's Notes

  1. Welcome to the Marketing of Medicines Program or SCRIPTS program. SCRIPTS stands for Southern Collaboration in Research to Impact Prescription of Therapeutics.