Drugs

Steps Proposed to Modernize U.S. Clinical Studies

A Duke Margolis Institute for Health Policy white paper, “From Research to Care: Modernizing U.S. Clinical Studies for Cures Into Care,” lists several priority actions that it says private organizations and collaborations need to take to reform the U.S. fragmented clinical research system. The report reviews the current inefficiencies of U.S. clinical research and the range of steps that could enhance the clinical trial research and development enterprise while also advancing early-stage studies. It recommends these priority actions:

build on and integrate emerging federal policy initiatives for preclinical and early-stage development through clear implementation goals, using Operation TrialBlazer and related initiatives to clarify risk-based requirements for first-in-human studies, expand regulatory guidance on new approach methodologies and model-informed drug development, and test accountable certification approaches for experienced research institutions;
accelerate validation of biomarkers, endpoints, and artificial intelligence-enabled methods;
leverage emerging health-data infrastructure to expand the use of clinical care data in research;
enable U.S. private sector leadership in bringing clinical trial platform and integration tools into care workflows;
support implementation through evidence-based legislative action and accountable federal funding to accelerate lead initiatives; and
accelerate global regulatory alignment to reduce duplicative development burdens, assure high-quality evidence, and improve access to innovative treatments worldwide.

“Together, these initiatives would enable the United States to build a more efficient and accessible clinical research enterprise that integrates evidence generation with care delivery and strengthens U.S. leadership in bringing biomedical innovation to patients,” the report concludes. It says that more research and bipartisan stakeholder engagement are needed to delve into the needed procedures, incentives, and policies to move the practical initiatives into implementation.

HHS Allows Compounding of 6 Peptides Despite FDA Staff Objections

HHS has announced an interim enforcement-discretion policy allowing state-licensed pharmacies, federal facilities and licensed physicians to compound six previously restricted peptides under specified conditions while FDA considers whether to formally authorize their use under Section 503A of the Federal Food, Drug, and Cosmetic Act. The 10/28 policy

Law Firm Provides Overview of Guide on Drug Use-Related Software

FDA’s recent final guidance Regulatory Considerations for Prescription Drug Use-Related Software provides sponsors with a “more concrete framework for navigating the boundary between FDA-required and promotional labeling, while placing a premium on early regulatory planning,” according to a new Akin legal analysis. The guidance outlines how prescription

FDA, EMA Working Together on Herbal/Botanical Drugs

A 9/25 joint FDA/European Medicines Agency (EMA) workshop on “Regulatory Perspectives on Herbal Medicinal/Botanical Drug Development” set the stage for future joint activities in the herbal/botanical space, despite regulatory differences in the ways in which the two jurisdictions approach the products. An interview in an FDA

Device Specificity Does Not Establish Insufficient Controls: AdvaMed

Commenting on an FDA proposal for classification of accessories distinct from other devices, including a proposed list of accessories suitable for Class 1, AdvaMed says that device specificity alone does not establish that general controls are insufficient. “Congress required FDA to classify each accessory based on its own risks, not

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HHS Allows Compounding of 6 Peptides Despite FDA Staff Objections

Law Firm Provides Overview of Guide on Drug Use-Related Software

FDA, EMA Working Together on Herbal/Botanical Drugs

Device Specificity Does Not Establish Insufficient Controls: AdvaMed