TITLE

GPhA: FDA Needs More Resources

PUB. DATE
February 2011
SOURCE
Chain Drug Review;2/28/2011, Vol. 33 Issue 4, p68
SOURCE TYPE
Trade Publication
DOC. TYPE
Article
ABSTRACT
The article reports that the Generic Pharmaceutical Association (GPhA) is recognizing that member companies' products will be moving expeditiously if the Food and Drug Administration (FDA) has sufficient resources in reviewing the Abbreviated New Drug Applications in the U.S.
ACCESSION #
59994649

 

Related Articles

  • Generic User Fee Legislation Moves Forward.  // Chain Drug Review;7/16/2012, Vol. 34 Issue 12, p62 

    The article reports that final congressional approval of the user fee proposals that were recently negotiated by the Generic Pharmaceutical Association (GPhA) and the U.S. Food and Drug Administration has won applause from the pharmaceutical industry.

  • Regulatory Workshop Set By FDA, GPhA.  // Chain Drug Review;4/23/2012, Vol. 34 Issue 8, p250 

    The article offers information on the U.S. Food and Drug Administration (FDA) and Generic Pharmaceutical Association's two day workshop to be held in Bethesda, Maryland on May 22-23, 2012.

  • GPhA responds to possibility of more stringent FDA regulations. DeArment, Alaric // Drug Store News;11/15/2010, Vol. 32 Issue 14, p29 

    The article focuses on the response of the Generic Pharmaceutical Association (GPhA) to the U.S. Food and Drug Administration's (FDA) adoption of tougher standards for certain classes of generic drugs.

  • GPhA concerned about FDA's proposed labelling changes.  // Reactions Weekly;Feb2014, Vol. 1488 Issue 1, p4 

    The article discusses the concerns of the Generic Pharmaceutical Association (GPhA) on the proposed drug labeling amendments to the "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" issued by the U.S. Food & Drug Administration in November 2013.

  • Prescribing Info May Go Electronic.  // Chain Drug Review;2/16/2015, Vol. 37 Issue 4, p78 

    The article reports that a rule proposed by the U.S. Food and Drug Administration, which would need manufacturers of prescription drugs to distribute product labeling information to health care providers electronically has been supported by the Generic Pharmaceutical Association (GPhA).

  • GPhA Urges Congress to Move on Generic and Biosimilar User Fees. Van Amum, Patricia // BioPharm International;May2012, Vol. 25 Issue 5, p10 

    The article reports on the move of Generic Pharmaceutical Association (GPhA) which urged the U.S. Congress to move forward with user-fee proposals for generic drugs and biosimilar products. It offers information on the proposed user-fee programs which were developed in 2011 by GPhA, Food and...

  • FDA Asked to Back Review of Caraco Ruling.  // Chain Drug Review;5/23/2011, Vol. 33 Issue 9, p76 

    The article reports that the Generic Pharmaceutical Association (GPhA) has urged the U.S. Food and Drug Administration to support the Supreme Court's review on a patent dispute between Caraco Pharmaceutical Laboratories Ltd. and Novo Nordisk AS.

  • FDA: Generic Industry Mature Enough for Full Responsibility. Serebrov, Mari // BioWorld Today;11/12/2013, Vol. 24 Issue 218, p1 

    The article focuses on the proposed regulation of the U.S. Food and Drug Administration (FDA) to give generic drugmakers the responsibility in labeling their products. This gives the generic drugmakers the ability to make safety changes while submitting changes being affected (CBE-0). However,...

  • GPhA Concerns.  // BioWorld Today;11/12/2013, Vol. 24 Issue 218, p5 

    The article focuses on the response of the Generic Pharmaceutical Association (GPhA) to the proposed regulation of the U.S. Food and Drug Administration (FDA) to give generic drugmakers the responsibility in product labeling. GPhA questions the authority of FDA to change the rule, claiming that...

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