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Forum on Drug Discovery, Development, and Translation 2018 Annual Report (2019) / Chapter Skim
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Looking Forward: Forum Activities in 2019
Pages 11-13

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Select key terms on the right to highlight them within pages of the chapter.


From page 11...
... The meeting may include discussions on current FDA guidelines regarding the quality and quantity of evidence required to support claims of safety and effectiveness in new drug applications. Additionally, meeting participants may discuss potential criteria and sources of data to guide decision making for generic label updates on indications, dosing, and adverse events, and approaches for addressing specific gaps in labeling, such as for certain patient populations (e.g., pediatric)
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From page 12...
... Workshop attendees will discuss the challenges and op portunities for the harmonization of guidelines for transparent reporting throughout the biomedical research lifecycle. The agenda will include a panel discussion on facilitating the development of consistent guidelines (e.g., a common set of minimal reporting standards)
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From page 13...
... Looking Forward: Forum Activities in 2019 Forum members (from left to right) Jeff Hurd, Gregory Keenan, and Joseph Menetski sharing their thoughts at the March 2018 Forum meeting.
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Key Terms

  • trial data
  • sharing clinical
  • data sharing
  • generic oncology
  • updating labels

  • fda guidelines
  • research lifecycle
  • label updates
  • specific gaps
  • oncology drugs

  • transparent reporting
  • meeting participants
  • minimizing risk
  • potential criteria
  • forum meeting

  • patient populations
  • cancer policy
  • support claims
  • evidence required
  • policy forum

  • generic label
  • discuss potential
  • addressing specific
  • forum staff
  • amanda wagner

  • staff amanda
  • guide decision
  • remaining gaps
  • increase transparency
  • public meeting


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