💊FDA Draft Guidance on Oncology Radiopharmaceuticals Dosage Optimization
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development." This guidance is intended to assist sponsors in identifying an optimized dosage for radiopharmaceutical therapies (RPT) for oncology indications during clinical development and prior to submitting a marketing application for a new indication and usage. The guidance provides considerations for RPT dosage optimization in RPT development programs.
Learn More📈FDA Guidance on Overall Survival Assessment in Oncology Trials
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Approaches to Assessment of Overall Survival in Oncology Clinical Trials." The purpose of this draft guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a prespecified safety endpoint. While the draft guidance discusses situations in which it is appropriate to consider overall survival for the primary endpoint, this draft guidance primarily focuses on statistical or design considerations when overall survival is not the primary endpoint.
Learn More💊FDA Issues Draft Guidance on Cancer Drug Combinations
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Development of Cancer Drugs for Use in Novel Combination--Determining the Contribution of the Individual Drugs' Effects." This draft guidance is intended for sponsors developing drugs for use in combination for the treatment of cancer and provides recommendations for characterizing the safety and effectiveness of individual drugs for use in a novel combination regimen in oncology (i.e., demonstrating the contribution of each drug to the overall effect that is observed for the population). This guidance expands on the recommendations in the 2013 guidance for industry entitled "Codevelopment of Two or More New Investigational Drugs for Use in Combination." This guidance does not address contribution of effect in settings where an investigational drug is being developed in combination with a drug approved for the same indication for the purposes of comparing the approved drug to the combination or to fixed combinations of previously approved drugs for the approved indication(s).
Learn More🧬FDA Proposes Reclassification of Hematology Devices Affecting ISH Systems
The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for this device type.
Learn More💊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.
Learn More🏥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.
Learn More💊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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