💊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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment."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.
Learn More💰Notice of Closed Meeting for NIH Grant Applications Review
The Department of Health and Human Services announces a closed meeting of the National Institute of Allergy and Infectious Diseases' Special Emphasis Panel. The agenda includes the review of grant applications related to clinical trial planning and implementation. Meeting proceedings are confidential to protect sensitive information related to the applications.
Learn More🧪NIH Notice of Closed Meeting for Grant Application Review
The National Institute of Allergy and Infectious Diseases has announced a closed meeting to review and evaluate grant applications. This meeting is part of ongoing federal efforts to advance research in allergy, immunology, and infectious diseases, and will address confidential aspects related to the applications under consideration.
Learn More💰NIH Closed Meetings for Grant Applications
The Department of Health and Human Services announces closed meetings of the National Institute of Allergy and Infectious Diseases to review grant applications. These meetings, aimed at evaluating funding proposals for clinical trials and infectious disease research, emphasize the confidentiality of discussions regarding sensitive commercial information and personal data.
Learn More💊Notice of Importer Application for Controlled Substances
Sharp Clinical Services, 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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