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Industry Lineup Is Set For OTC Hearing

March 24, 2014

Public hearings get underway on March 25.

The OTC Monograph Public Meeting begins tommorrow, March 25,  at the Food and Drug Administration's White Oak campus in Silver Springs, MD. FDA would like input on how to improve the current OTC Monograph Process for reviewing certain nonprescription drugs. The public hearing is being held to obtain information and comments from the public on the strengths and weaknesses of the current OTC Monograph Process, the feasibility of potential modifications the Agency has identified, and ideas about other modifications or alternatives to this process. The meeting continues on March 26.

Here's the lineup of presenters:

March 25, 2014
9:00 am: Janet Woodcock, MD, Director, Center for Drug Evaluation and Research
9:15 am: Robert Guidos, JD, Senior Advisor to the Director, CDER
9:30 am: William Soller, University of California, San Francisco
9:45 am: Scott Melville, David Spangler, Barbara Kochawaski, Consumer Healthcare Products Association
10:15 am: Scott Bass, SidleyAustin, LLP
10:30 am: Break
10:45 am: Lauren Quinn, Novartis Consumer Health Inc.
11:00 am: Greg Collier, Procter and Gamble Company
11:15 am: Elizabeth Anderson, Personal Care Products Council
11:30 am: Lunch
12:30 pm: Leo Beletsky, Northeastern University School of Law & Bouve College of Health
12:45 pm:  Greg O’Neill, The Gerontological Society of America
1:00 pm: Craig Weiss, Independent Cosmetic Manufacturing and Distribution, ICMAD
1:15 pm: Gabrielle Cose, The PEW Charitable Trust
1:30 pm: Jim Czaban, Wiley Rein
1:45 pm: Valerie Ramsey, CB Fleet Company, Inc.
2:00 pm: Break
2:15 pm: Lynne Szczepaniak, Ed Kuffner, McNeil Consumer Healthcare Products
2:35 pm: Kathleen Neville, MD, American Academy of Pediatrics
2:50 pm: Peter Barton Hutt
3:05 pm: Closing Remarks

March 26, 2014
9:00 am: Opening Remarks, Robert Guidos
9:15 am: Daniel Hussar, Philadelphia College of Pharmacy
9:30 am: David Steinberg, Steinberg and Associates
9:45 am: Richard Kingham, Covington and Burling, LLP
10:00 am: Ann Begley, Morgan, Lewis, Brockius
10:15 am: David Schoneker, IPEC Americas
10:30 am: Closing Remarks.

FDA Panel
Presiding Officer: Robert Guidos, JD
• Carol Bennett, JD, Acting Director, Office of Compliance, CDER
• Thomas J. Cosgrove, JD, Director, Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, CDER
• Peter Diak, PharmD, MPH, Team Leader, Division of Pharmacovigilance II, Office of Surveillance and Epidemiology, CDER
• Leslie Kux, JD, Assistant Commissioner for Policy, Office of Policy, Planning and Legislation, Office of the Commissioner
• Theresa M. Michele, MD, Director, Division of Nonprescription Clinical Evaluation, CDER


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