Skip to main content

Forum on Drug Discovery, Development, and Translation 2013 Annual Report (2014) / Chapter Skim
Currently Skimming:

Looking Forward: Forum Activities in 2014
Pages 9-11

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 9...
... Since that time, FDA has worked to develop an enhanced structured approach to the assessment of benefits and risks in drug regulatory decision making to better communicate this aspect of the human drug review process. An extensive body of evidence informs regulatory decisions on June 23 April 21 Workshop: Breakthrough November 30 Discussion Series: Business Models: Drug Discussion Series: A Conversation Science at FDA: Challenges Development for Rare with Tony Fauci and Opportunities and Neglected Diseases 2008 February 20–21 June 23–24 Discussion Series: Comparative Symposium: Diseases and Individualized Effectiveness (Forum Meeting #9)
Read the entire page →
From page 10...
... the sources October 24 November 5 March 13 Workshop: Assessing and Workshop: Addressing the Threat Discussion Series: FDA Community Accelerating Development of of Drug-Resistant Tuberculosis: A Update on Personalized Medicine and Biomarkers for Drug Safety Realistic Assessment of the Challenge the Genetic Basis of Adverse Events 2009 February 23 November 3 Capitol Hill Briefing: Growing Forum Meeting #11 Threat of Drug-Resistant Tuberculosis
Read the entire page →
From page 11...
... The members of the Clinical Trial Site Accreditation Action Collaborative will meet for the third time on March 11, 2014, to discuss the findings of the working groups on a process for standards development, and on the establishment of a mechanism to facilitate a process to align and improve clinical trial site standards. Participants are preparing a Perspective paper to be published by the IOM.
Read the entire page →

Key Terms

  • clinical trial
  • trial site
  • drug safety
  • site accreditation
  • improve clinical

  • accreditation action
  • action collaborative
  • regulatory decisions
  • clinical forum
  • drug regulatory

  • drug regulation
  • drug discussion
  • drug review
  • transforming clinical
  • tony fauci

  • site standards
  • key considerations
  • challenges development
  • informs regulatory
  • potential analytical

  • enhanced structured
  • structured approach
  • national accreditation
  • genetic basis
  • neglected diseases

  • realistic assessment
  • transfer negotiations
  • commissioner peggy
  • breakthrough november
  • community update


    • This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
    More information on Chapter Skim is available.