TITLE

The Food and Drug Administration Amendments Act of 2007: Drug safety and health-system pharmacy implications

AUTHOR(S)
Meyer, Brian M.
PUB. DATE
December 2009
SOURCE
American Journal of Health-System Pharmacy;12/15/2009, Vol. 66 Issue 24, pS3
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article focuses on the drug safety provisions of the Food and Drug Administration Amendments Act (FDAAA) of 2007 like the risk evaluation and mitigation strategies (REMS) and the significance on pharmacists. It mentions that FDAAA amends the Federal Food, Drug and Cosmetic Act and authorize the U.S. Food and Drug Administration (FDA) to demand post marketing studies and clinical trials on human drugs and REMS. It notes that standardization ensures drug safety with the knowledge on risks.
ACCESSION #
46824018

 

Related Articles

  • Risk management Shapes FDA Policies and Practices. Wechsler, Jill // Pharmaceutical Technology North America;Aug2002, Vol. 26 Issue 8, p12 

    Reports on initiatives of U.S. Federal Drug and Administration (FDA) to prompt manufacturers to assess and address drug safety issues. Importance of identifying risks associated with the use of medical products to reduce adverse events; Need for additional funding to enhance adverse-event data...

  • FDA Refocuses to Boost Post-Market Safety.  // Bioworld Week;3/3/2008, Vol. 16 Issue 9, p4 

    The article reports on the move of the Food and Drug Administration (FDA) in applying the same standards it uses in its premarket drug reviews to manage its post-marketing safety process. According to the article, FDA is expanding its Office of Surveillance and Epidemology (OSE) to settle...

  • Specialty pharmacy's role in REMS, FDA's new drug safety program. Russek, Steven B. // Formulary;Oct2009, Vol. 44 Issue 10, p300 

    Prescription drug safety is a topic that generates a great deal of attention in the headlines, among patient communities, and in the US civil court system. A problem arises when a drug offers significant therapeutic benefits but also carries challenging health or safety risks. FDA recently...

  • Kaiser Questions Safety Policies. Wechsler, Jill // Pharmaceutical Executive;Feb2010, Vol. 30 Issue 2, p18 

    The article reports on the petition of Kaiser Permanente to the Food and Drug Administration (FDA) on the growing number of approved Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) of drugs in the U.S. It mentions that Kaiser is concerned on the diverse...

  • Revising REMS: FDA is looking to streamline processes for ensuring safe and appropriate use of high-risk drugs. Wechsler, Jill // Pharmaceutical Executive;Sep2010, Vol. 30 Issue 9, p14 

    The article focuses on the insights of healthcare providers on the effectiveness of the U.S. Food and Drug Administration's (FDA) program for establishing Risk Evaluation and Mitigation Strategies (REMS) designed to oversee safety of high-risk drugs. It notes that physicians, pharmacists as well...

  • Risk Evaluation and Mitigation Strategies (REMS): Educating the Prescriber. Nicholson, Susan C.; Peterson, Janet; Yektashenas, Behin // Drug Safety;2012, Vol. 35 Issue 2, p91 

    The US FDA Amendments Act of 2007 was signed into law on 27 September 2007. A provision of this law granted the FDA new powers to enhance drug safety by requiring the pharmaceutical industry to develop Risk Evaluation and Mitigation Strategies (REMS). REMS are deemed necessary when a question...

  • What's Missing in This REMS? Credible Patient-Outcome Data. Serebrov, Mari // BioWorld Today;12/2/2011, Vol. 22 Issue 233, p1 

    The article discusses efforts during a meeting of the U.S. Food and Drug Administration's (FDA) Drug Safety and Risk Management, and Dermatologic and Ophthalmic Drug advisory committees, to determine whether a risk evaluation and mitigation strategy (REMS) with elements to assure safe use, is...

  • FDA Struggles to Meet Review Goals. Wechsler, Jill // Applied Clinical Trials;May2008, Vol. 17 Issue 5, p28 

    The article discusses how the U.S. Food and Drug Administration (FDA) struggles to meet review goals. It states that the FDA faces several challenges such as depleted resources, personnel issues and the implementation of the FDA Amendments Act (FDAAA). The FDA may require the implementation of...

  • Assuring Safety of Inherently Unsafe Medications: the FDA Risk Evaluation and Mitigation Strategies. Nelson, Lewis; Loh, Meredith; Perrone, Jeanmarie // Journal of Medical Toxicology;Jun2014, Vol. 10 Issue 2, p165 

    The decision to approve a drug for clinical use is based on an understanding of its benefits versus the risks. Although efficacy is generally understood at the time of submission to the FDA for approval, the risks are more difficult to assess. Both PubMed (from 2000 to 2012) and the FDA website...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics