How FDA approves drugs and regulates their safety and effectiveness

FDA Drug Approval: Elements and Considerations

Volumn , Issue , 2012, Pages 1-28

  Thaul, Susan ^a  

^a NONE

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EID: 84946761508     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (22)

1. FDA, "Abbreviated New Drug Application (ANDA): Generics," http://www.fda.gov/Drugs/ DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/ AbbreviatedNewDrugApplicationANDAGenerics/default.htm.
2. FDA, "Inside Clinical Trials: Testing Medical Products in People; What Is a Clinical Trial?" Information for Consumers, http://www.fda.gov/Drugs/ResourcesForYou /Consumers/ucm143531.htm.
3. FDA, "New Drug Application (NDA): Introduction," http://www.fda.gov/Drugs/Development ApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications /NewDrug ApplicationNDA/default.htm.
4. FDA, "Office of Surveillance and Epidemiology (OSE)," CDER, http://www.fda.gov /AboutFDA/CentersOffices/ CDER/ucm106491.htm.
5. FDA, "Drug Safety and Risk Management Advisory Committee," http://www.fda.gov /AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/default.htm.
6. FDA, "Drug Safety Oversight Board," http://www.fda.gov/AboutFDA/CentersOffices/CDER /ucm082129.htm.
7. FDA, "Compliance Policy Guide: CPG Sec. 160.900 Prescription Drug Marketing Act- Pedigree Requirements under 21 CFR Part 203," http://www.fda.gov/ICECI/Compliance Manuals/CompliancePolicyGuidanceManual/ ucm073857.htm.
8. FDA, "Statement on Adderall," FDA Statement, February 9, 2005, at http://www.fda.gov/bbs/topics/news/2005/NEW01156.html
9. Gardiner Harris, "Warning Urged on Stimulants Like Ritalin," New York Times, February 10, 2006
10. Karen E. Lasser, Diane L. Seger, D. Tony Yu, et al., "Adherence to Black Box Warnings for Prescription Medications in Outpatients," Archives of Internal Medicine, vol. 166, Feb. 13, 2006, pp. 338-344.
11. FDA, "Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices; Final rule," Federal Register, v. 73, no. 164, August 22, 2008, pp. 49603-49610.
12. FDA, "MedWatch: The FDA Safety Information and Adverse Event Reporting Program," http://www.fda.gov/ Safety/MedWatch/default.htm
13. FDA "Adverse Event Reporting System (AERS)," http://www.fda.gov/Drugs/ InformationOnDrugs/ucm135151.htm.
14. FDA, "Review Management: Risk Management Plan Activities in OND and ODS," Manual of Policies and Procedures, MAPP 6700.1, CDER (Originator: Office of New Drugs), effective September 8, 2005, http://www.fda.gov/downloads/AboutFDA/Centers Offices/ CDER/ManualofPoliciesProcedures/ucm082058.pdf.
15. Toni Piazza-Hepp, FDA presentation: "Risk Management Programs," at the Risk Management Public Workshop, CDER, Washington, D.C., April 10, 2003, at http://www.fda.gov/cder/meeting/RMtranscript2.doc
16. FDA, Center for Drug Evaluation and Research 2004 Report to the Nation: Improving Public Health Through Human Drugs, August 2005, at http://www.fda.gov/cder/reports/rtn/2004/rtn2004.pdf.
17. Gardiner Harris, "System Said to Fail to Steer Women From Acne Drug," New York Times, February 11, 2006.
18. FDA, "Drug Safety Newsletter," http://www.fda.gov/Drugs/DrugSafety/DrugSafety Newsletter/default.htm and http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNews letter /ucm096049.htm.
19. FDA, "Drug Safety Communications," http://www.fda.gov/drugs/drugsafety/ postmarket drugsafetyinformationforpatientsandproviders/ucm199082.htm.
20. FDA, "FDA Drug Safety Podcasts," http://www.fda.gov/Drugs/DrugSafety/Drug Safety Podcasts/default.htm.
21. FDA, "FDA Drug Info Rounds," http://www.fda.gov/Drugs/ResourcesForYou/Health Professionals/ucm211957.htm.
22. FDA, "FDA Drug Information (FDA_Drug_Info) on Twitter," http://twitter.com/FDA_ Drug_Info.