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The US Food and Drug Administration (FDA) is seeking stakeholder feedback to create a Quantitative Medicine Innovation Network (QMIN), a cross-sector platform that uses quantitative medicine approaches to accelerate drug development and regulatory science and improve clinical decision-making.

The US Food and Drug Administration (FDA) has published two guidances on transdermal or topical delivery systems (TDS) for generic drugs, including a final guidance on assessing adhesives for TDS products and a draft guidance on assessing skin irritation using in vivo studies in TDS products.

Most adult cancer drugs approved by the US Food and Drug Administration (FDA) over the past two decades were regular approvals for expanded indications based on surrogate endpoints, rather than accelerated approvals, according to a study published in JAMA on Thursday.

The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trials. The documents address three areas: a patient’s performance status, laboratory values, and washout periods.

Time between a drug’s entry into clinical trials and its approval for reimbursement was similar in four major markets, according to a cross-sectional analysis published in JAMA Health Forum.

Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the time of approval. Of those, the vast majority of study results were published in ClinicalTrials.gov or another publication, according to an article published Thursday in JAMA Network Open.

The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing to sufficiently inform subjects about the clinical trial they were participating in.

The US Food and Drug Administration (FDA) has finalized its guidance on clinical trial requirements for developing psychedelic therapies. The final version clarifies the agency's thinking, based on industry feedback, especially regarding clinical and safety considerations in the design of clinical trials.

The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to issue in 2026, including 22 final and 43 proposed rules by the US Food and Drug Administration (FDA).

Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) technologies can help improve early-phase clinical trials. They also said the agency should develop a governance structure with specific metrics and goals and consider aligning its thinking with other regulators.