The Future of Drug Safety

The Future of Drug Safety PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309103045
Category : Medical
Languages : en
Pages : 347

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Book Description
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

The Future of Drug Safety

The Future of Drug Safety PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133947
Category : Medical
Languages : en
Pages : 346

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Book Description
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

Congressional Record

Congressional Record PDF Author: United States. Congress
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 1478

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Book Description


Category C Submission Efficacy Reviews [electronic Resource]

Category C Submission Efficacy Reviews [electronic Resource] PDF Author: Canada. Pest Management Regulatory Agency. Submission Coordination and Documentation Division
Publisher:
ISBN: 9780662325918
Category :
Languages : en
Pages :

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Russell, Hugo and Ayliffe's Principles and Practice of Disinfection, Preservation and Sterilization

Russell, Hugo and Ayliffe's Principles and Practice of Disinfection, Preservation and Sterilization PDF Author: Adam P. Fraise
Publisher: John Wiley & Sons
ISBN: 1444333259
Category : Medical
Languages : en
Pages : 626

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Book Description
The new edition of this established and highly respected text is THE definitive reference in its field. It details methods for the elimination or prevention/control of microbial growth, and features: New chapters on bioterrorism and community healthcare New chapters on microbicide regulations in the EU, USA and Canada Latest material on microbial resistance to microbicides Updated material on new and emerging technologies, focusing on special problems in hospitals, dentistry and pharmaceutical practice Practical advice on problems of disinfection and antiseptics in healthcare A systematic review of sterilization methods, with uses and advantages outlined for each Evaluation of disinfectants and their mechanisms of action with respect to current regulations The differences between European and North American regulations are highlighted throughout, making this a truly global work, ideal for worldwide healthcare professionals working in infectious diseases and infection control.

Safe and Effective Medicines for Children

Safe and Effective Medicines for Children PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309225493
Category : Medical
Languages : en
Pages : 432

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Book Description
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Agriculture, Rural Development, and Related Agencies Appropriations

Agriculture, Rural Development, and Related Agencies Appropriations PDF Author: United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related Agencies
Publisher:
ISBN:
Category :
Languages : en
Pages : 666

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Agriculture, Rural Development, and Related Agencies Appropriations for Fiscal Year 2007

Agriculture, Rural Development, and Related Agencies Appropriations for Fiscal Year 2007 PDF Author: United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related Agencies
Publisher:
ISBN:
Category : United States
Languages : en
Pages : 668

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Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2003: Agricultural programs

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2003: Agricultural programs PDF Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Publisher:
ISBN:
Category : Political Science
Languages : en
Pages : 1548

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Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations For 2006, Part 7, March 9, 2005, 109-1 Hearings, *

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations For 2006, Part 7, March 9, 2005, 109-1 Hearings, * PDF Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 1040

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Code of Federal Regulations

Code of Federal Regulations PDF Author:
Publisher:
ISBN:
Category : Administrative law
Languages : en
Pages : 256

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Book Description