📈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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Approaches to Assessment of Overall Survival in Oncology Clinical Trials." The purpose of this draft guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approval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 While the draft guidance discusses situations in which it is appropriate to consider overall survival for the primary endpoint, this draft guidance primarily focuses on statistical or design considerations when overall survival is not the primary endpoint.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💊Benuvia Operations LLC Applies for Controlled Substances Import Registration
Benuvia Operations, LLC. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More🏥TRICARE Regulation Expands Coverage for Clinical Trials
The Assistant Secretary of Defense for Health Affairs (ASD(HA)) issues this final rule regarding circumstances under which services and supplies related to emerging treatments may be covered under the TRICARE program. This rule finalizes provisions published in two interim final rules (IFRs) with request for comment, which temporarily added coverage for the treatment use of investigational drugs under U.S. Food and Drug Administration (FDA)-authorized expanded access (EA) programs when for the treatment of coronavirus disease 2019 (COVID-19) and permitted coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19. This final rule discusses the DoD's decision not to make permanent the coverage of treatment use of investigational drugs under FDA EA programs while updating language for care associated with their administration and broadens the COVID-19 clinical trial benefit to include coverage of clinical trials sponsored or approved by any National Institutes of Health (NIH) Center or Institute to treat or prevent infectious diseases associated with a pandemic or epidemic. Lastly, the final rule expands TRICARE's clinical trial benefit by covering services and supplies provided in conjunction with Phase I, II, III, and IV clinical trials that are NIH-sponsored or approved and that involve a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition is severely debilitating, life- threatening, or a rare disease.
Learn More👩⚕️Draft Guidance on Pregnant and Breastfeeding Women in Clinical Trials
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide general principles on the conduct of clinical trials that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these populations. The draft guidance includes approaches to generating data that support informed decision-making on the safety, dosing, and efficacy of medicinal products during pregnancy and breastfeeding. Additionally, the draft guidance includes recommendations for recruiting and retaining pregnant and breastfeeding women in clinical trials, while reducing burden and harm on these participants.
Learn More💊FDA Guidance on Developing Treatment for Myelodysplastic Syndromes
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment." The purpose of this guidance is to assist sponsors in the clinical development of drug and biological products for the treatment of the myelodysplastic syndromes (MDS). Specifically, this guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for the development of drug and biological products to support an indication of treatment of MDS. This guidance will focus specifically on development of drug and biological products that are considered disease-modifying and, therefore, will not cover products considered supportive only (e.g., erythropoiesis-stimulating agents). Furthermore, the guidance will not address drug development for MDS/myeloproliferative neoplasms, such as chronic myelomonocytic leukemia, which are considered a separate class of myeloid neoplasms.
Learn More💊DEA Notice on AndersonBrecon's Controlled Substance Import Application
AndersonBrecon, Inc. DBA PCI Pharma Services has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More📄FDA Announces M11 Technical Specification for Clinical Trials
The Food and Drug Administration (FDA or Agency) is announcing the availability of the revised draft technical specification entitled "M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol (CeSHarP)" and a supplemental document entitled "M11 Template." The revised draft technical specification and template were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The revised draft technical specification recommends the use of an open, nonproprietary standard to enable electronic exchange of clinical protocol information. The template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange. These ICH documents create an international standard for the content and exchange of clinical trial protocol information facilitating review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This revised draft technical specification and updated template revise and replace the draft versions of the same titles issued in December 2022.
Learn More🩺National Cancer Institute Meeting Notice - Opportunities for Businesses
The Department of Health and Human Services announces a virtual meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. Open to public participation, the meeting will discuss significant research programs, offering stakeholders an opportunity to engage and provide input on the agenda.
Learn More💊Almac Clinical Services' Importer Application for Controlled Substances
Almac Clinical Services, Inc., (ACSI) has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊Notice of Application for Controlled Substances by Myonex LLC
Myonex LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
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