FDA's Drug Approval Process: Up to the Challenge? : Hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, First Session, on Examining Food and Drug Administration's (FDA) Drug Approval Process, Focusing on FDA's Drug Approval Process After a Sponsor Demonstrates that Their Benefits Outweigh Their Risks for a Specific Population and Use, and that the Drug Meet [sic] Meets Standards for Safety and Efficacy, March 1, 2005 |
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... tients and practitioners can take to prevent or mitigate harm . This information re- source will significantly enhance public knowledge and understanding of safety issues by discussing emerging or potential safety problems even before ...
... tients and practitioners can take to prevent or mitigate harm . This information re- source will significantly enhance public knowledge and understanding of safety issues by discussing emerging or potential safety problems even before ...
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... tients , physicians , and the industry to enhance the critical path . And finally , the FDA must be adequately resourced to implement a comprehensive suite of reforms . Just as I started my testimony with a quote from Wendy Dixon , I ...
... tients , physicians , and the industry to enhance the critical path . And finally , the FDA must be adequately resourced to implement a comprehensive suite of reforms . Just as I started my testimony with a quote from Wendy Dixon , I ...
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... tients not only to improve access and quality of care , but also to support a strong national commitment to the research and development necessary to produce innova- tive medical tools that are both safe and effective II . Understanding ...
... tients not only to improve access and quality of care , but also to support a strong national commitment to the research and development necessary to produce innova- tive medical tools that are both safe and effective II . Understanding ...
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... tients to have earlier access to new therapies . Under PDUFA , the FDA collects user fees from industry to supplement annual appropriations for review of new drug ap- plications . According to the Government Accountability Office ( GAO ) ...
... tients to have earlier access to new therapies . Under PDUFA , the FDA collects user fees from industry to supplement annual appropriations for review of new drug ap- plications . According to the Government Accountability Office ( GAO ) ...
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... tients infected with HIV . The Office of Drug Safety is responsible for monitoring AERS . However , this system has significant limitations . It is based on voluntary submission of MedWatch forms for adverse events that caregivers ...
... tients infected with HIV . The Office of Drug Safety is responsible for monitoring AERS . However , this system has significant limitations . It is based on voluntary submission of MedWatch forms for adverse events that caregivers ...
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AACAP adverse drug reactions Advisory Committee agency antidepressants approved drugs assess authority to require Bextra black box warning cancer CDER CHAIRMAN child and adolescent children and adolescents clinical trials companies conduct CONGRESS THE LIBRARY consumers Cox-2 inhibitors DAVENPORT-ENNIS depression detect disease doctors drug approval process drug products drug review drug safety drug safety issues Drug Watch ensure evaluation FDA need FDA's drug important improve increase KWEDER labeling changes LIBRARY OF CONGRESS medical products medicines monitoring NSAIDs Office of Drug patients PDUFA pediatric percent physicians population post-marketing postmarket studies potential prescription drugs Psychiatry public health Question randomized trials regulatory safe and effective safety and efficacy safety risks safety signals scientific Scott Gottlieb Senator BURR SENATOR ENZI Senator KENNEDY Senator MURRAY side effects sponsor SSRI stroke testimony Thank therapies tients tion treatment options user fees Vioxx
Popular passages
Page 42 - AACAP is the leading national medical association dedicated to treating and improving the quality of life for the estimated 7-12 million American youth under 18 years of age who are affected by emotional, behavioral, developmental and mental disorders. AACAP supports research, continuing medical education and access to quality care. Child and adolescent psychiatrists are the only medical specialists fully trained in the treatment of mental illness in children and adolescents.
Page 91 - ... is intended for the treatment of a serious or life-threatening condition and it demonstrates the potential to address unmet medical needs for such a condition.
Page 10 - FDA's post-market safety program to help further ensure that America's drug product supply is safe and effective, and of the highest quality. Under this proposal, CDER's ODS would receive increased funding to expand the Agency's ability to rapidly survey, identify and respond to potential safety concerns for drugs on the market. ODS will hire additional staff to manage and lead safety reviews, will increase the number of staff with expertise in critical areas such as risk management, risk communication...
Page 11 - ODS would receive increased funding to expand the Agency's ability to rapidly survey, identify and respond to potential safety concerns for drugs on the market. ODS will hire additional staff to manage and lead safety reviews, will increase the number of staff with expertise in critical areas such as risk management, risk communication and epidemiology, and will increase access to a wide range of clinical, pharmacy and administrative databases. The Administration's proposed budget for ODS will increase...
Page 78 - Board (DSB) to provide independent oversight and advice on the management of important drug safety issues and to manage the dissemination of certain safety information through FDA's website to health care professionals and patients.
Page 15 - CONCLUSION At FDA, providing the American public with safe and effective medical products is our core mission. We base decisions to approve a drug, or to keep it on the market if new safety findings surface, on a careful balancing of risk and benefit to patients. This is a multifaceted and complex decision process, involving scientific and public health issues. The recent initiatives we have announced will improve our current system to assess drug safety. Moreover, we will continue to evaluate new...
Page 14 - FD-AJVfA authorized FDA to grant an additional six months of marketing exclusivity (known as pediatric exclusivity) to pharmaceutical manufacturers that conduct studies of certain drugs in pediatric populations. The objective of section 111 was to promote pediatric safety and efficacy studies of drugs. With the valuable information generated by these studies, the product labeling can then be updated to include appropriate information on use of the drug in the pediatric population. To qualify for...
Page 10 - ... of patient and consumer groups. FDA will also increase the transparency of the Agency's decision-making process by establishing new and expanding existing communication channels to provide drug safety information to the public. These channels will help ensure that established and emerging drug safety data are quickly available in an easily accessible form. The increased openness will enable patients and their health care professionals to make better-informed decisions about individual treatment...
Page 14 - This information provides a rich source of valuable safety information to allow pediatricians to make more informed decisions about whether and how to use these drugs in their patients. Post-Marketing Safety Studies On April 30, 2001, FDA's regulations implementing section 130 of FDAMA, which requires sponsors of approved drugs and biologics to report annually on the status of post-marketing commitments, became effective.
Page 11 - Phase III of IND. Phase III studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in phase II and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. Phase III studies also provide an adequate basis for extrapolating the results to the general population and transmitting that information in...