Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "M15 General Principles for Model-Informed Drug Development." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance discusses the multidisciplinary principles of model-informed drug development (MIDD). This includes recommendations on MIDD planning, model evaluation, and evidence documentation. The draft guidance also includes a harmonized framework for assessing evidence derived from MIDD. The draft guidance is intended to facilitate multidisciplinary understanding, appropriate use, and harmonized assessment of MIDD and its associated evidence.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2024-D-5580] ( printed page 106504) AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “M15 General Principles for Model-Informed Drug Development.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance discusses the multidisciplinary principles of model-informed drug development (MIDD). This includes recommendations on MIDD planning, model evaluation, and evidence documentation. The draft guidance also includes a harmonized framework for assessing evidence derived from MIDD. The draft guidance is intended to facilitate multidisciplinary understanding, appropriate use, and harmonized assessment of MIDD and its associated evidence. DATES: Submit either electronic or written comments on the draft guidance by February 28, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments…
Other Federal Register documents from the same docket.
Citation: 89 FR 106504
