The Adequacy of FDA to Assure the Safety of the Nation's Drug Supply: Hearing Before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, First Session, February 13, March 22, 2007, Volume 4 |
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... Woosley , Raymond L. , M.D. , president and chief executive officer , the Critical Path Institute 245 Prepared statement 289 Answers to submitted questions 314 SUBMITTED MATERIAL Angell , Marcia , M.D. , et al , letter of March 14 ...
... Woosley , Raymond L. , M.D. , president and chief executive officer , the Critical Path Institute 245 Prepared statement 289 Answers to submitted questions 314 SUBMITTED MATERIAL Angell , Marcia , M.D. , et al , letter of March 14 ...
Page 202
... Woosley is someone that I had the opportunity to work with when he was at our fine Vanderbilt University Medical Center as a researcher in the mid - 1980's and I was the chairman of the board for the American Lung Association in ...
... Woosley is someone that I had the opportunity to work with when he was at our fine Vanderbilt University Medical Center as a researcher in the mid - 1980's and I was the chairman of the board for the American Lung Association in ...
Page 240
... Woosley , president and CEO of Critical Path Institute . As you know , it is the practice of this committee to take all testi- mony under oath . I would ask each witness to stand and raise their right hand , please . [ Witnesses sworn ] ...
... Woosley , president and CEO of Critical Path Institute . As you know , it is the practice of this committee to take all testi- mony under oath . I would ask each witness to stand and raise their right hand , please . [ Witnesses sworn ] ...
Page 245
... WOOSLEY , M.D. , PRESIDENT AND CHIEF EXECUTIVE OFFICER , THE CRITICAL PATH INSTITUTE Dr. WOOSLEY . Mr. Chairman , members , thank you for the oppor- tunity to provide testimony to the subcommittee on this very im- portant topic . As ...
... WOOSLEY , M.D. , PRESIDENT AND CHIEF EXECUTIVE OFFICER , THE CRITICAL PATH INSTITUTE Dr. WOOSLEY . Mr. Chairman , members , thank you for the oppor- tunity to provide testimony to the subcommittee on this very im- portant topic . As ...
Page 247
... Woosley appears at the conclu- sion of the hearing . ] Mr. STUPAK . Thank you , Dr. Woosley . Tab four in that big binder has the open letter to Chairman Ken- nedy , Chairman Dingell , and members of this committee . You were talking ...
... Woosley appears at the conclu- sion of the hearing . ] Mr. STUPAK . Thank you , Dr. Woosley . Tab four in that big binder has the open letter to Chairman Ken- nedy , Chairman Dingell , and members of this committee . You were talking ...
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adverse events Advisory Committee meeting Agency AIDAC meeting Andrew von Eschenbach Anti-Infective Anti-infective Drugs antibiotics approved Ketek asked Aventis black box warning BURGESS CDER Chairman Chuck Grassley clinical trials Commissioner concerns conduct Congress criminal investigation data integrity data integrity problems decision-making decisions DEGETTE Division Director documents drug application drug approval e-mail effective ESCHENBACH evaluation FDA employees FDA managers FDA officials FDA's February 13 Food and Drug fraud FURBERG going hearing inspection integrity issues Ketek NDA Kirkman-Campbell Kweder label liver failure look Mark Goldberger Medicine monitoring muraglitazar Oversight and Investigations patients PDUFA pneumonia post-marketing postmarket drug safety postmarket safety PSATY public health questions recommendations regulatory requests response Review Division Risk Management Advisory Ross safety data safety study Sanofi-Aventis scientific STUPAK subcommittee submitted telithromycin testimony Thank Vioxx WALDEN whistleblowers WHITFIELD WOOSLEY
Popular passages
Page 215 - The right of persons employed in the civil service of the United States, either individually or collectively, to petition 'Congress, or any Member thereof, or to furnish information to either House of Congress, or to any committee or member thereof, shall not be denied or interfered with.
Page 81 - ... a substantial scientific issue essential to determining the safety or effectiveness of the drug has been identified after the testing has begun.
Page 80 - If the intent of the trial is to show similarity of the test and control drugs, the report of the study should assess the ability of the study to have detected a difference between treatments. Similarity of test drug and active control can mean either that both drugs were effective or that neither was effective. The analysis of the study should explain why the drugs should be considered effective in the study, for example, by reference to results in previous placebo-controlled studies of the active...
Page 245 - Mr. Chairman, this concludes my prepared remarks. I would be happy to respond to any questions you or other members of the Subcommittee may have at this time.
Page 270 - All of our work was conducted in accordance with generally accepted government auditing standards. In summary, we found that...
Page 123 - We are of opinion that the power of inquiry — with process to enforce it — is an essential and appropriate auxiliary to the legislative function.
Page 123 - That a committee be appointed to inquire into the causes of the failure of the late expedition under Major General St. Clair; and that the said Committee be empowered to call for such persons, papers, and records, as may be necessary to assist their inquiries.
Page 1 - PREPARED STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN Thank you Mr.
Page 29 - Thank you, Mr. Chairman, and members of the committee. Good morning. My name is John Powers.
Page 304 - Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee that was held to discuss reports of suicidal thoughts and actions in children with major depressive disorder for various antidepressant drugs. OND believed that the ODS staff member's analysis, which showed a relationship between the use of antidepressants and suicidal thoughts and behaviors in children, was too preliminary to be presented in detail.