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U.S. Department of Health and Human Services

Drugs

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Drug GMP Steering Committee

Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach

 

Janet Woodcock, MD, CDER, Chair
Maureen Hess, MPH, RD, CDER, Project Manager

ORA Members CBER Members
Walt Brown Mark Elengold
Doug Ellsworth Mary Malarkey
Michael Rogers Steven Masiello
John Taylor  
 
CDER Members OC Members
Joe Famulare Michael M. Landa
David Horowitz, Esq. Theresa Mullin, PhD
Ajaz Hussain, PhD Janet Showalter
Helen Winkle  
  CVM Members
  Bill Marnane, MS
  Gloria Dunnavan
 
**CDRH Members **CFSAN Members
Kim Trautman, MS Joe Baca
**voting rights limited to only those issues that would affect the Center, e.g., the shift of Part 11 to CDER