FDA wants your two cents on math-powered drug revolution network
Published Date: 8/5/2026
Notice
Summary
The Center for Drug Evaluation and Research (CDER) within the Food and Drug Administration (FDA or Agency), through its Quantitative Medicine Center of Excellence (QM CoE), is announcing a request for information to inform the development of a Quantitative Medicine Innovation Network (QMIN). The vision for the QMIN is to create a cross-sector collaborative platform that accelerates the translation of quantitative medicine approaches to transform drug development, regulatory science, and clinical decision-making for patient benefit. The purpose of this request is to obtain feedback from industry, academia, healthcare providers, patient groups, and other interested parties on identifying critical community needs and establishing mechanisms for continuous engagement, supporting collaborative demonstration projects or research on innovative approaches aimed at addressing high priority areas through the application of QM approaches, and exploring mechanisms to leverage community expertise and capacity to promote QM innovation and adoption. Information submitted in response to this request will be considered in shaping the structure, priorities, and activities of the QMIN.
No Economic Impacts Identified for this Document
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-15920, Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing
The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by Buchanan Ingersoll & Rooney PC, on behalf of Micro-Tracers, Inc. (Micro-Tracers or objector), on the order granting a color additive petition (3C0323) requesting that we repeal specified regulations to no longer provide for the safe use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. We are also providing notice that the administrative stay of the effective date for the repeal and delisting of the color additive regulations is now lifted.
2026-15612, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs." This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA's recommendations and expectations related to in vivo skin irritation and in vivo combined skin irritation and sensitization studies. This draft guidance replaces the draft guidance "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs" (April 2023).
2026-15636, Ricardo Andres Acuna: Final Debarment Order
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Ricardo Andres Acuna from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ricardo Andres Acuna was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Mr. Acuna was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of May 6, 2026 (30 days after receipt of the notice), Mr. Acuna has not responded. Mr. Acuna's failure to respond and request a hearing constitutes a waiver of Mr. Acuna's right to a hearing concerning this matter.
2026-15613, Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs." This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The guidance replaces the draft guidance (Revision 2) "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs," issued on April 13, 2023.