Search Results for keywords:"clinical trial design"

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Search Results: keywords:"clinical trial design"

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  • 2025-04026 — E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Reopening of the Comment Period
    Type:Notice
    Citation:90 FR 11985
    Reading Time:about 5 minutes

    The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance titled "E6(R3) Good Clinical Practice: Annex 2," originally announced on December 30, 2024. This guidance provides updated recommendations on clinical trial design and conduct, especially those involving digital elements and real-world data. The reopening is intended to give people more time to submit comments by March 31, 2025, before the final version is prepared. The FDA made this decision following requests for extra time to develop more comprehensive feedback.

    Simple Explanation

    The FDA wants to give people more time to share their thoughts on new rules for running medical tests that might use gadgets and real-world data. They've reopened the period when people can send in their ideas until the end of March 2025.

  • 2025-00213 — Developing Drugs for Optical Imaging; Draft Guidance for Industry; Availability
    Type:Notice
    Citation:90 FR 1504
    Reading Time:about 6 minutes

    The Food and Drug Administration (FDA) has announced the release of draft guidance titled "Developing Drugs for Optical Imaging." This guidance aims to provide advice to drug sponsors on designing clinical trials to develop and approve optical imaging drugs used with imaging devices during surgeries. Optical imaging drugs help surgeons identify tumors and differentiate them from normal tissue, enhancing surgical safety and effectiveness. Public comments on the draft can be submitted until April 8, 2025, although feedback is welcomed anytime.

    Simple Explanation

    The FDA made a new guide to help companies create special medicine that makes it easier for doctors to see things inside the body during surgery, like finding hidden lumps or normal body parts, using bright lights. People can tell the FDA what they think about this guide until April 2025.