Notice 8 May 2025 regulatory compliance, public comment, pharmaceuticals, fda, drug approval, oncology

💊FDA Oncologic Drugs Advisory Committee Meeting Notice

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

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Notice 12 Mar 2025 regulatory, nih, health, meeting, scientific review, oncology

🏥Amended Notice of Meeting - Center for Scientific Review, NIH

The Department of Health and Human Services announces a change in the meeting schedule for the Oncology 2—Translational Clinical Integrated Review Group, including a new contact for the Scientific Review Officer. The meeting is closed to the public and takes place at the National Institutes of Health in Bethesda, MD.

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Regulatory Compliance, Pharmaceutical Development 17 Jan 2025 compliance, healthcare, fda, drug development, oncology, chemotherapy

💊FDA Guidance on Chemotherapy-Induced Peripheral Neuropathy Available

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology." Chemotherapy-induced peripheral neuropathy (CIPN), a painful, disabling, and potentially irreversible condition commonly affecting patients receiving neurotoxic chemotherapies, could diminish survival by potentially increasing chemotherapy treatment interruptions, dose reductions, and discontinuations. This guidance provides recommendations to sponsors for the clinical development of drug and biological products intended for the prevention and treatment of CIPN in oncology patient populations.

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