Presentations by Steven K. Galson, M.D., MPH

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FDA/Center for Drug Evaluation and Research

Presentations by Steven K. Galson, M.D., MPH
CDER Center Director

2007

CDER Update, WCBP, January 29, 2007 [PDF]
Prescription Drug Use Fee Act (PDUFA IV), Public Meeting, February 16, 2007 [PDF]
FDA Response to the IOM Report, College of Preventative Medicine, February 24, 2007 [PDF]

2006

CDER Update (2005), Stanford Washington Research Group, January 17, 2006 [PDF]
CDER Update (2006), Stanford Washington Research Group, January 18, 2006 [PDF]
What's New in CDER, ORA San Francisco District Office, January 23, 2006 [PDF]
Drug Regulation Update, 10th Annual Symposium on the Inerface of Regulatory & Analytical Sciences for Biotechnology Health Products, January 24, 2006 [PDF]
FDA Drug Approval: Ensuring Patient Safety and Access in Today's Fast-Changing World of Pharmaceuticals, Howard University, February 8, 2006 [PDF]
Controversy in Drug Regulation: Ensuring Patient Safety and Access, Mount Sinai School of Medicine, March 2, 2006 [PDF]
CDER Update, Lehman Brothers 9th Annual Global Healthcare Conference, March 10, 2006 [PDF]
FDA/Industry Conference, Temple University School of Medicine, March 29, 2006 [PDF]
CDER Breakout Session, FDLI 49th Annual Conference, April 7, 2006 [PDF]
Opportunities in Personalized Medicine, Science Forum, Douglas C. Throckmorton, M.D., April 16, 2006 [PDF]
The Changing Regulatory Climate: FDA Perspective, Post-Approval Summit at Harvard, May 8, 2006 [PDF]
OMB Proposed Risk Assessment Bulletin and its Potential Impact on FDA, National Academy of Sciences Meeting, May 22, 2006 [PDF]
Unique Challenges for Pharmaceuticals, Institute of Medicine, May 30, 2006 [PDF]
Understanding the Benefits and Risks of Pharmaceuticals: Opening Remarks, Institute of Medicine, May 30-31, 2006 [PDF]
Disscussion Slides, Institute of Medicine, May 30-31, 2006 [PDF]
Drug Regulation - 2006 Chemical Heritage Foundation Philadelphia, May 16, 2006 [PDF]
Drug Safety 2006: What You Need to Know, Financial Women's Association, June 12, 2006 [PDF]
CDER Office of Management and Budget Visit, August 8, 2006 [PDF]
CDER U.S. House Appropriations Briefing, August 30, 2006 [PDF]
Drug Approvals for 2005, Healthcare Innovations, September 12-13, 2006 [PDF]
State of CDER, October 4, 2006 [PDF]
Center Director's Update, GPhA Technical Conference, October 18, 2006 [PDF]
Presentation to the American Public Health Association, November 6, 2006 [PDF]
CDER Overview, Harvard University, November 7, 2006 [PDF]
CDER Update, Johnson and Johnson, November 14, 2006 [PDF]
Critical Path and Drug Safety: Progress and Updates, PhRMA Conclave, November 30, 2005
FDA Drug Approval: Ensuring Patient Safety and Access in Today's Fast-Changing World of Pharmaceuticals, National Health Council, December 2, 2006 [PDF]
CDER Update, Windhover FDA/CMS Summit, December 4, 2006 [PDF]

2005

The Future of Drug Development and Regulation in the United States, Piper Jaffray 17th Annual Healthcare Conference, January 26, 2005 [PDF]
Current Issues in Drug Regulation at FDA, February 2, 2005 [PDF]
Program Background and Preparation for FY 2006 Appropriations Hearings, February 11, 2006 [PDF]
Current Issues in CDER, Generic Pharmaceutical Association, February 25, 2005 [PDF]
Drug Safety in Controversy: FDA Actions, Johns Hopkins Boomberg School of Public Health, March 15, 2005 [PDF]
Setting Drug Specifications in the 21st Century, PQRI Workshop, March 16, 2005 [PDF]
Drug Safety Initiative: FDA Science Board, April 15, 2005 [PDF]
Controversies in Drug Regulation, Oregon Health Resources Commission, April 21, 2005 [PDF]
Changes to Enhance Customer Needs, FDA Science Board, April 27, 2005 [PDF]
Current Issues in Drug Regulation at FDA, Sigma Xi, May 6, 2005 [PDF]
Controversies in Drug Regulation, Health Communications Research Center at the Missouri School of Journalism and the Missouri Arthritis Rehabilitation Research and Training Center, May 12, 2005 [PDF]
Committee on the Assessment of the U.S. Drug Safety System: Charge to the Committee, National Academeies Institute of Medicine, June 8, 2005 [PDF]
Issues in Drug Regulation, Marwood Group, June 28, 2005 [PDF]
Issues in Drug Regulation, National Venture Capital Association, September 27, 2005 [PDF]
PhRMA Drug Safety Panel for Patient Advocates, September 28, 2005 [PDF]
Challenges and Opportunities in Drug Development and Manufacturing, CMC Workshop, October 7, 2005 [PDF]
A New Era of Regulatory Progress, GPhA Fall Technical Conference, October 24, 2005 [PDF]
CDER Drug Safety Update, FDA Science Board, November 6, 2005 [PDF]
PDUFA IV Public Meeting, November 14, 2005 [PDF]
Critical Path and Drug Safety: Progress and Updates, PhRMA Conclave, November 30, 2005 [PDF]
FDA Drug Approval: Ensuring Patient Safety and Access in Today's Fast-Changing World of Pharmaceuticals, December 2, 2005 [PDF]
Drug Safety in the U.S.: Patient Safety and Access in Today's Fast-Changing World of Phamaceuticals, American Public Health Association, December 14, 2005 [PDF]

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Date created: February 28, 2007; updated March 12, 2007