Search Results for keywords:"Draft Guidance"

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Search Results: keywords:"Draft Guidance"

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  • 2024-31027 — M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Draft Guidance for Industry; Availability
    Type:Notice
    Citation:89 FR 106504
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) has released a draft guidance document titled "M15 General Principles for Model-Informed Drug Development." This document was created under the International Council for Harmonisation (ICH) and provides recommendations on planning, evaluating, and documenting evidence in drug development using models. It aims to help harmonize regulations globally, enhancing drug development and improving manufacturing standards. Public comments on the draft can be submitted until February 28, 2025.

    Simple Explanation

    The FDA wrote a guide to help scientists use special models when making new medicines, so everyone around the world can agree on the best ways to do this. People can share their thoughts about it until February 2025, but the guide might be a little tricky to understand because it uses big words and doesn't always explain what they mean.

  • 2025-00237 — Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction; Draft Guidance for Industry; Availability
    Type:Notice
    Citation:90 FR 1502
    Reading Time:about 6 minutes

    The FDA has released a draft guidance titled "Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction" for public comment. This draft provides recommendations for developing drugs aimed at long-term weight loss and maintenance for individuals with obesity or overweight. It updates a previous guidance issued in 2007 and covers aspects like trial design, participant selection, and safety evaluations. The public can submit comments on the draft until April 8, 2025, to help shape the final version.

    Simple Explanation

    The FDA has shared a draft plan that gives tips on how to make new medicines to help people lose weight and keep it off. People can read this plan and tell the FDA what they think until April 8, 2025.

  • 2025-01179 — Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Extension of Comment Period
    Type:Notice
    Citation:90 FR 5899
    Reading Time:about 4 minutes

    The Food and Drug Administration (FDA) is extending the time for public comments on its draft guidance concerning the expedited approval process for drugs and biologics intended for serious conditions. Originally published on December 6, 2024, the comment period has been extended by 30 days, now closing on March 6, 2025. This extension was granted following requests expressing that the initial 60 days were insufficient to provide thorough feedback. The draft guidance aims to streamline the approval pathway for treatments addressing critical health issues.

    Simple Explanation

    The FDA is giving people more time to say what they think about new rules for quickly approving important medicines, like if you're really sick and need new treatments. They were supposed to finish talking about it by February, but now they have more time until March 6, 2025.

  • 2024-31524 — Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability
    Type:Notice
    Citation:90 FR 1166
    Reading Time:about 8 minutes

    The Food and Drug Administration (FDA) has released a draft guidance document titled "Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." This document provides general advice on evaluating donor eligibility, including screening and testing procedures. It also updates existing guidelines and plans to introduce additional guidance to help minimize communicable disease risks from donors. Public feedback on these recommendations can be submitted electronically or in writing until February 6, 2025.

    Simple Explanation

    The FDA has shared a plan to check if people who give human cells and tissues are safe, like making sure they don't spread bad germs or diseases. They want everyone to say what they think about this plan before it becomes final.