TITLE

Adverse Event Reports Go Digital Only

PUB. DATE
October 2009
SOURCE
Pharmaceutical Representative;Oct2009, Vol. 39 Issue 10, p9
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article reports on the proposal of the Food and Drug Administration (FDA) to require pharmaceutical companies to submit post-marketing adverse event reports in an electronic format in the U.S. The FDA's proposal aims waste on paper submissions and identify safety concerns as well as share safety information. The Center for Drug Evaluation and Research of the FDA allows drug companies to submit forms in an electronic format through a pilot program.
ACCESSION #
44722400

 

Related Articles

  • The First Nine Months. NEUER, ANN // Bio-IT World;Sep2008, Vol. 7 Issue 7, p31 

    The article reports on the status of the mandate to use electronic common technical document (eCTD) format implemented by the Center for Drug Evaluation and Research (CDER) division of the U.S. Food and Drug Administration (FDA). According to Virginia Ventura, regulatory information specialist...

  • FDA to address post-marketing. Comer, Ben // Medical Marketing & Media;Oct2009, Vol. 44 Issue 10, p12 

    The article reports that more 80% of the manufacturers have presented their post marketing information to the U.S. Food and Drug Administration (FDA) despite the agency's weakness to monitor and tract the manufacturers. John Jenkins, director, office of the new drugs of Center for Drug...

  • FDA Gains Support for e-Submissions, Standards. Wechsler, Jill // Applied Clinical Trials;Jun2011, Vol. 20 Issue 6, p18 

    The article offers information on the support that the Food and Drug Administration (FDA) received about its plans to add a modern scientific computing system in the U.S. It states that FDA is desperately in need of modern scientific computing system to deal with large volumes of data from a...

  • Regulatory Regime.  // U.S. Pharma & Healthcare Report;Q2 2012, Issue 2, p15 

    The article discusses U.S. pharmaceuticals regulation as performed by the Food and Drug Administration (FDA) through approvals of products, high manufacturing standards and labelling. It cites FDA approval of over-the-counter (OTC) and prescription drugs through the Center for Drug Evaluation...

  • REGULATORY ROUNDUP.  // Pharmaceutical Technology;May2013, Vol. 37 Issue 5, p24 

    The article offers news briefs of the U.S. as of 2013 related to the pharmaceutical industry. Veteran Kathleen Uhl was appointed to manage the U.S. Food and Drug Administration's (FDA) Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research of the U.S.(CDER). The FDA has...

  • Drug Shortages Create Crisis for Manufacturers, Regulators. Wechsler, Jill // BioPharm International;Nov2011, Vol. 24 Issue 11, p12 

    The article focuses on the drug shortage in the U.S. It states that the country is experiencing medical disruptions due to drug-manufacturing and pharmaceutical supply-chain failings. Deputy Director Doughlas Throckmorton of the U.S. Food & Drug Administration's (FDA) Center for Drug Evaluation...

  • Don't ask, don't tell. Conlan, Michael F. // Drug Topics;4/24/95, Vol. 139 Issue 8, p58 

    Reports on the effort of the Food and Drug Administration (FDA) to protect the identities of pharmacists and other health professionals who voluntarily submit reports of adverse drug and device events. FDA rule's preemption of any state or local law or regulation requiring disclosure;...

  • For opiate management, FDA pledges to balance enforcement, palliative care needs. Traynor, Kate // American Journal of Health-System Pharmacy;6/1/2009, Vol. 66 Issue 11, p968 

    The article discusses a decision made by the U.S. Food & Drug Administration (FDA) in reference to unapproved morphine sulfates on March 30, 2009. The FDA now pledges to do more research before making important decisions. The article includes comments from Douglas Throckmorton of the FDA's...

  • Costs and Compliance Dominate Agenda for 2011. Wechsler, Jill // Pharmaceutical Technology;Jan2011, Vol. 35 Issue 1, p26 

    The article offers information on the programs of the U.S. Food and Drug Administration (FDA) for pharmaceutical manufacturers. It states that the Prescription Drug User Fee Act (PDUFA) needs to be reauthorized by October 1, 2012 for FDA to proceed collecting around 700 million dollars payment....

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