Evaluating the Effectiveness of the Food And Drug Administration Modernization Act: Hearing Before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, First Session, May 3, 2001, Volume 4 |
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... Director JAMES D. BARNETTE , General Counsel REID P.F. STUNTZ , Minority Staff Director and Chief Counsel SUBCOMMITTEE ON HEALTH MICHAEL BILIRAKIS , Florida , Chairman CONTENTS Page Testimony of : Applebaum , Rhona S. ,. MICHAEL ...
... Director JAMES D. BARNETTE , General Counsel REID P.F. STUNTZ , Minority Staff Director and Chief Counsel SUBCOMMITTEE ON HEALTH MICHAEL BILIRAKIS , Florida , Chairman CONTENTS Page Testimony of : Applebaum , Rhona S. ,. MICHAEL ...
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... Director , Medical Device Manufacturers Association Plunkett , Travis B. , Legislative Director , Consumer Federation of Amer- ica ...... Suydam , Linda A. , Senior Associate Commissioner , Food and Drug Ad- ministration Material ...
... Director , Medical Device Manufacturers Association Plunkett , Travis B. , Legislative Director , Consumer Federation of Amer- ica ...... Suydam , Linda A. , Senior Associate Commissioner , Food and Drug Ad- ministration Material ...
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... director of Pediatric Pharmacology Research Unit at Children's Mercy , and the clinics . It's to me a very great effort that this subcommittee is making to take this up ahead of time and to try to reauthorize it because from everything ...
... director of Pediatric Pharmacology Research Unit at Children's Mercy , and the clinics . It's to me a very great effort that this subcommittee is making to take this up ahead of time and to try to reauthorize it because from everything ...
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... Director of the Medical Device Manufacturers Association , and Dr. Rhona Applebaum , Executive Vice President of Scientific and Regulatory Affairs for the National Food Proc- essors Association . Ms. Suydam , since you are the ...
... Director of the Medical Device Manufacturers Association , and Dr. Rhona Applebaum , Executive Vice President of Scientific and Regulatory Affairs for the National Food Proc- essors Association . Ms. Suydam , since you are the ...
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... Director of the Medical Device Manufacturers Association based here in Washington , DC . MDMA is the national voice for the entrepreneurial sector of our industry . The association was founded in 1992 by a group of entre- preneurs who ...
... Director of the Medical Device Manufacturers Association based here in Washington , DC . MDMA is the national voice for the entrepreneurial sector of our industry . The association was founded in 1992 by a group of entre- preneurs who ...
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active moieties additional adults adverse events agency agency's applications atric BEN-MAIMON benefits BILIRAKIS blockbuster drugs breakthrough CDRH Center Chairman Children's Mercy Hospital clinical trials committee conduct Congress consumers cost dietary supplements disease Drug Administration drug applications drug approval drug companies drug development Drug User Fee ensure FDA's Food and Drug FRANSON guidance document health claims implementation important improve incentive program issue label changes least burdensome legislation Lewin Group manufacturers MDMA medical devices medicines Medtronic MICHAEL BILIRAKIS million Modernization Act months off-label PDUFA pedi pediatric drug pediatric exclusivity provision pediatric patients pediatric research pediatric studies pediatricians percent PhRMA post-market premarket prescription drugs provisions of FDAMA public health Question reauthorization regulations regulatory Response review process safe and effective safety scientific STUPAK Subcommittee submission SUYDAM technologies testing Thank therapeutic therapies third party review tion Tufts CSDD user fees written requests