TITLE

FDA moves closer to new requirements for NTI drugs

AUTHOR(S)
Traynor, Kate
PUB. DATE
September 2011
SOURCE
American Journal of Health-System Pharmacy;9/1/2011, Vol. 68 Issue 17, p1568
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article reports that the definition of narrow therapeutic index (NTI) drugs proposed by the FDA received near-unanimous support from the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology at a meeting held July 26, 2011 in Silver Spring, Maryland. The proposed definition requires NTI drugs to have steep dose-response curves for safety and efficacy. Included are comments from Lawrence Yu, deputy director for science and chemistry at FDA's Office of Generic Drugs.
ACCESSION #
65535839

 

Related Articles

  • Biosimilars: Ambiguity of FDA Terminology and Benefits of a Multidisciplinary Review Team. Doyle, Chase // Oncology Pharmacist;Feb2015, Vol. 8 Issue 1, p1 

    No abstract available.

  • Fate of cost-saving biosimilar drugs may hinge on naming policy. Johnson, Steven Ross // Modern Healthcare;7/6/2015, Vol. 45 Issue 27, p0007 

    The article discusses the prediction of some experts that the labeling of biosimilar products will be a major factor in determining the success of the biosimilars industry. Topics covered include the importance of biosimilars in controlling the increasing drug costs. Also mentioned is the...

  • Demystifying generics.  // Consumer Reports on Health;Aug2012, Vol. 24 Issue 8, p9 

    The article presents an interview with pharmaceutical scientist Vinod P. Shah. He describes the U.S. Food and Drug Administration (FDA) approval requirements for generic drugs, discusses the effects of generic drugs with a narrow therapeutic index (NTI) on certain patients, and notes the...

  • Pipeline preview.  // Formulary;Feb2013, Vol. 48 Issue 2, p53 

    The article reports on consideration which the U.S. Food and Drug Administration is giving in 2013 to approving the drug Rytary for treating Parkinson's disease. A discussion of drugs, including Elafin, Ezatiostat and Enobosarm, which the agency has given fast track, priority review or orphan...

  • Using the Drug Dissolution Test for the Characterization of Generics: Ofloxacin Tablets. Dorofeev, V. L.; Titov, I. V.; Kochin, V. Yu.; Arzamastsev, A. P. // Pharmaceutical Chemistry Journal;May2004, Vol. 38 Issue 5, p264 

    Examines conditions for the drug dissolution test to differentiate ofloxacin generics and validate their production. Study materials and methods; Factors influencing the drug release during the dissolution test; U.S. Food and Drug Administration instructions concerning the dissolution test for...

  • Regulatory Considerations for Controlled Correspondence Related to Generic Drug Chemistry. Adams, Kristina; Xiaochuan Yang; Min Li; O'Connor, Thomas; Christensen, Lane; Holcombe Jr., Frank; Raw, Andre; Rosencrance, Susan; Wu, Geoffrey // Pharmaceutical Technology;2015 Supplement API's, Excipients, & Manufacturing 2015, Vol. 39 

    The article discusses a study analyzes controlled correspondence between generic-drug manufacturers and the U.S Food & Drug Administration (FDA), revealing patterns in questions about specific drug chemistry topics. Topics discussed include the controlled correspondence that is submitted to the...

  • GPhA spotlights patent reform. Buono, Drew // Drug Store News;3/3/2008, Vol. 30 Issue 3, p39 

    Information about several issues discussed at the recent Generic Pharmaceutical Association's annual meeting is presented. It examines the issues from the ongoing need for approval of biogeneric legislation in the U.S. to the overall impact generic drugs will have on Americans in 2008 and...

  • How safe is Synthroid? Patients want to know. Lewis, Jillene // Drug Topics;8/6/2001 Supplement, Vol. 145 Issue 15, p16 

    Discusses the danger of using oral levothyroxine sodium drug products in the United States. Issuance of guidelines by the Food and Drug Administration (FDA) on the consumption of levothyroxine drug products; Approval from the FDA on the use of Synthroid; Lack of consistent potency and stability...

  • Are Generics Equivalent to Brand-Name Drugs?  // USA Today Magazine;Feb2003, Vol. 131 Issue 2693, p11 

    Discusses the effectiveness of generic drugs compared with their brand-name counterparts. Ratings of generic drugs according to the U.S. Food and Drugs Administration; Reason for the increase in demand for generic drugs.

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