Editor's Commentary: Regulatory Science and the Science of Safety

Hamburg MA . Remarks at the National Press Club Speaker Luncheon. October 6, 2010. http://www.fda.gov/NewsEvents/Speeches/ucm229195.htm (accessed January 5, 2011).

Food and Drug Administration. Strategic priorities 2011–2015: responding to the public health challenges of the 21st century (draft). http://www.fda.gov/downloads/AboutFDA/ReportManualsForms/Reports/StrategicActionPlan/UCM226907.pdf (accessed January 5, 2011).

Food and Drug Administration. The Sentinel Initiative: national strategy for monitoring medical product safety. 2008. http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM124701.pdf (accessed February 12, 2011).

Food and Drug Administration. The Sentinel Initiative: access to electronic healthcare data for more than 25 million lives: achieving FDAAA Section 905 goal one. http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM233360.pdf (accessed February 12, 2011).

Institute of Medicine of the National Academies. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: National Academies Press; 2007. (Report released September 2006, published in book form in 2007: see also http://iom.edu/Reports/2006/The-Future-of-Drug-Safety-Promoting-and-Protecting-the-Health-of-the-Public.aspx. accessed February 12. 2011.).

110th US Congress. Food and Drug Administration Amendments Act; September 2007. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/FullTextofFDAAALaw/default.htm (accessed February 12, 2011).

Food and Drug Administration. Prescription Drug User Fee Act (PDUFA): adding resources and improving performance in FDA review of new drug applications. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDruUserFee/ucm119253.htm (accessed February 12, 2011).

Turner JR . Drug safety, medication safety, patient safety: An overview of recent FDA guidances and initiatives. Reg Rapporteur. 2009;(April):4–8.

Turner JR Durham TA . Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance. Hoboken, NJ: Wiley; 2009.

Food and Drug Administration. Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. Agenda. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM222622.pdf (accessed February 12, 2011).

Food and Drug Administration. Final questions to the advisory committee. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteeMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM222625.pdf (accessed February 12, 2011).

Food and Drug Administration. Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisorvCommittee/UCM222628.pdf (accessed February 12, 2011).

Food and Drug Administration. Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. http://www.fda.gov/downloads/AdvisoryCommittees/CommiteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM222629.pdf (accessed February 12, 2011).

Sutter S Davis J . FDA, EMA decisions on Avandia reflect the power of REMS. Pink Sheet: Prescription Pharmaceuticals and Biotechnology. 2010; September 27: 1, 4–6.

Center for Drug Evaluation and Research Update: improving public health through human drugs. 2007. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/WhatWeDo/UCM121704.pdf (accessed February 12, 2011).

Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC: National Academies Press: 2000.

Food and Drug Administration. Public workshop on the safe use initiative. November 16, 2010. http://www.fda.gov/downloads/Drugs/NewsEvents/UCM235767.pdf (accessed February 12, 2011).

West LJ . Medicines Control Agency (MCA) and other regulatory authorities. In International Drug Surveillance Department, Glaxo Group Research, Drug Safety: A Shared Responsibility. New York: Churchill Livingstone; 1991:89–97.

Turner JR Satin LZ Callahan TS Litwin JS . The science of cardiac safety. Appl Clin Trials. 2010; 19 (11, Suppl):4–8, 14.

Cobert B . Manual of Drug Safety and Pharmacovigilance. Sudbury, MA: Jones and Bartlett; 2007.

Senn S . Statistical Issues in Drug Development. 2nd ed. Chichester, UK: John Wiley; 2007.

O'Neill RT . Statistical analyses of adverse event data from clinical trials: Special emphasis on serious events. Drug Inf J. 1987; 21: 9–20.

Peace KE . Design, monitoring, and analysis issues relative to adverse events. Drug Inf J. 1987; 21: 21–28.

O'Neill RT . A perspective on characterizing benefits and risks derived from clinical trials: Can we do more? Drug Inf J. 2008; 42: 235–245.

O'Neill RT . Biostatistical considerations in pharmacovigilance and pharmacoepidemiology: Linking quantitative risk assessment in pre-market licensure application safety data, post-market alert reports, and formal epidemiological studies. Stat Med. 1999; 17: 1851–1858.

Durham TA Turner JR . Introduction to Statistics in Pharmaceutical Clinical Trials. London: Pharmaceutical Press: 2008.