Compliance program supports IND and IDE research applications

July 2009
Clinical Trials Administrator;Jul2009, Vol. 7 Issue 7, p77
The article focuses on the establishment of the Office for Investigator-Sponsored Investigational New Drugs (IND) and Investigational Device Exemptions (IDE) Support at the University of Pittsburgh in Pennsylvania in August 2007. According to office director Dennis Swanson, all sponsor investigator IND and IDE applications are required to be submitted to the U.S. Food and Drug Administration (FDA). The issues which led to the establishment of the office are explained.


Related Articles

  • Perspectives from CROs on the Australian clinical trial environment.  // Australasian Biotechnology;Jul2015, Vol. 25 Issue 2, p29 

    The article presents clinical research organizations' perspectives on the trends and important happenings in the operating environment for clinical trials in Australia as of July 2015. Topics include the impact of technology on clinical trial execution, the value of sector collaborations to...

  • Korean city taps N.J. as first partner in medical complex. P, SHANKAR // njbiz;11/2/2009, Vol. 22 Issue 44, p6 

    The article reports that Daegu, Korea's third-largest city, will build the 5.6 billion dollars High-Tech Medical Complex in New Jersey. The complex will focus on drug development, clinical trials, and medical devices technology. Kim Bumil, mayor of Daegu, met with state officials to sign an...

  • Prduct Review.  // Urology Times;Apr2004, Vol. 32 Issue 5, p45 

    Presents news briefs concerning urologic drugs and devices, compiled as of April 1, 2004. Inclusion of Atrix Laboratories Inc.'s submission of a new drug application for leuprolide acetate for injectable suspension (Eligard), a product for hormone-sensitive advanced prostate cancer; NexMed...

  • Recent Trends and Success Factors in Reducing the Lag Time to Approval of New Drugs in Japan. Honig, P K // Clinical Pharmacology & Therapeutics;May2014, Vol. 95 Issue 5, p467 

    For many years, approvals of new drugs in Japan have lagged behind those in the United States and Europe. As a result of simultaneous global development strategies, more widespread inclusion of Japan in multiregional clinical trials, and significant reforms and investment in Japan's...

  • Panel Discussion 8.  // Annals of Oncology;2016 Supplement, Vol. 27, pvii60 

    No abstract available.

  • Mayo Clinical Trial Services.  // Applied Clinical Trials;Dec2005, Vol. 14 Issue 12, p131 

    The article provides information about a pharmaceuticals company, Mayo Clinical Trial Services (MCTS). With the full-service operational capabilities of a major contract research organization, MCTS combines the clinical expertise and academic leadership of world-renowned Mayo Clinic. For more...

  • Oversight and Enforcement in Clinical Trials. Wechsler, Jill // Applied Clinical Trials;Sep2000, Vol. 9 Issue 9, p19 

    Reports government inspection and regulation of clinical trial studies in the United States. Selection of clinical sites; Impact of the regulation on the relationship between research oversight and drug development; Recommendations for site inspection; Negligence in reporting clinical trial...

  • New User Fee Program Aims to Spur Drug Development. Wechsler, Jill // Applied Clinical Trials;Aug2002, Vol. 11 Issue 8, p18 

    Reports on the revised user fee program signed into law by U.S. President George W. Bush to encourage clinical trials for drug development. Enhancement of ability of public health agencies to respond to bioterrorist threats; Total approval time for new drug applications; Review of...

  • Business News.  // Applied Clinical Trials;Aug2002, Vol. 11 Issue 8, p56 

    Presents news items on clinical trials for drug development as of August 2002. Budapest-based Hungarian Regulatory Affairs Society's membership in Leefdaal, Belgium-based Pan European Federation of Regulatory Affairs Societies; Entry of Port Jefferson, New York-based Symbio LLC into...


Read the Article


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

Try another library?
Sign out of this library

Other Topics