U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). PDF Download
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Languages : en
Pages :
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Book Description
Features the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) in Rockville, Maryland, which is responsible for evaluating new drugs and regulating the manufacture, labeling, and advertising of drug products. Posts contact information via mailing address, telephone and fax numbers, and e-mail. Contains consumer articles, organization directories, annual reports, and top drug news. Provides the Orange Book files on dosage forms, formulations, products, and routes. Includes the FDA Drug Approvals list. Links to the FDA home page.
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Features the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) in Rockville, Maryland, which is responsible for evaluating new drugs and regulating the manufacture, labeling, and advertising of drug products. Posts contact information via mailing address, telephone and fax numbers, and e-mail. Contains consumer articles, organization directories, annual reports, and top drug news. Provides the Orange Book files on dosage forms, formulations, products, and routes. Includes the FDA Drug Approvals list. Links to the FDA home page.
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 27
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309179440
Category : Medical
Languages : en
Pages : 128
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Book Description
As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.
Author: Center for Drug Evaluation and Research (U.S.)
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 44
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Book Description
Author: Center for Drug Evaluation and Research (U.S.)
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 64
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Book Description
Author:
Publisher: DIANE Publishing
ISBN: 9781422326244
Category :
Languages : en
Pages : 12
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309048370
Category : Medical
Languages : en
Pages : 239
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Book Description
Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
Author: Center for Drug Evaluation and Research (U.S.)
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 48
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Book Description
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 34
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Book Description
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 20
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Book Description
Accompanied by supplements.
