TITLE

EUA or eIND? Testing drugs in an emergency

PUB. DATE
June 2010
SOURCE
IRB Advisor;Jun2010, Vol. 10 Issue 6, p67
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article focuses on Emergency Use Authorization (EUA) process and emergency Investigational New Drug (eIND) regulation, drug distribution mechanisms used by the Food and Drugs Administration (FDA). It discusses two mechanisms based on the H1N1 emergency that happened last 2009, where the FDA was reportedly issuing EUAs for antiviral drugs. Andrea Meyerhoff, an infectious disease specialist at Johns Hopkins School of Medicine in Baltimore, Maryland, suggests that eIND should be used instead of EUA.
ACCESSION #
50615119

 

Related Articles

  • FDA Actions.  // Critical Care Alert;Dec2009 Pharmacology Watch, p2 

    The article reports on the approval of the Food and Drug Administration (FDA) on the use of IV antiviral peramivir for treatment of inpatients with 2009 H1N1 influenza in the U.S.

  • New molecular entities/new biologics.  // Formulary;Apr2003, Vol. 38 Issue 4, p182 

    Reports on the U.S. Food and Drug Administration's approval of enfuvirtide, an anti-HIV drug. Efficacy; Safety; Dosing; Availability; Cost.

  • Pipeline preview.  // Formulary;Feb2009, Vol. 44 Issue 2, p32 

    A list of drugs at various stages in the U.S. Food and Drug Administration (FDA) approval pipeline is presented, including Asenapine (Saphris), Certolizumab pegol (Cimzia), and Olanzapine.

  • Week in Washington.  // BioWorld Insight;7/16/2012, Vol. 20 Issue 29, p6 

    The article offers the U.S. Food and Drug Administration news brief as of July 2012 on the topics including approval of the Food and Drug Administration (FDA) to risk evaluation of opioid drugs, signing of FDA Safety and Innovation Act and suing of FDA by K-V Pharmaceuticals Inc.

  • New class of anti-HIV drug approved.  // European Pharmaceutical Executive;Jun2007, p9 

    The article reports on the recommendation of the U.S. Food and Drug's (FDA) Antiviral Drugs Advisory Committee on the approval of Pfizer Inc.'s maraviroc, a chemokine receptor (CCR5) antagonist. It is designed to treat patients infected with CCR5-tropic human immunodeficiency virus-1 (HIV),...

  • Siga files application for emergency use of antiviral drug.  // PharmaWatch: Biotechnology;May2008, Vol. 7 Issue 5, p10 

    The article reports on the submission of an application by Siga Technologies Inc. to support an emergency use authorization of its orally active, smallpox antiviral drug ST-246. The emergency use authorization mechanism enables the U.S. Food and Drug Administration (FDA) Commissioner to...

  • ViroPharma Shares Drop as Maribavir Fails Phase III.  // Bioworld Week;2/16/2009, Vol. 17 Issue 7, p3 

    The article reports on the decline of shares of ViroPharma Inc. by 53% due to the failure of its antiviral drug maribavir to meet its primary endpoint of preventing cytomegalovirus (CMV) disease in a Phase III trial in patients undergoing stem cell transplant. It has also failed to hit secondary...

  • Aurobindo gets US-FDA nod for AIDS drug.  // Chemical Business;Jul2005, Vol. 19 Issue 7, p57 

    Reports on the approval of the antiretroviral agent lamivudine developed by Aurobindo Pharma Ltd. by the U.S. Food and Drug Administration. Use of the drug in the U.S. President's Emergency Plan for AIDS Relief program; Significance of the health program to AIDS patients.

  • Antiviral Briefs.  // AIDS Patient Care & STDs;Nov2008, Vol. 22 Issue 11, p917 

    The article offers news briefs related to developments related to antiviral agents. Pfizer Inc. has released data from a study of HIV patients, in which findings point to the need for proper patient selection prior to treatment with CCR5 therapies. The U.S. Food and Drug Administration (FDA)...

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

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

Try another library?
Sign out of this library

Other Topics