🧬FDA Draft Guidance on Clinical Trials for Gene Therapy Products
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft document entitled "Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations." The draft guidance document provides recommendations to sponsors who are planning clinical trials of cell and gene therapy (CGT) products intended for use in a disease or condition that affects a small population, generally one that meets the definition of a rare disease or condition under section 526(a)(2) of the FD&C Act (21 U.S.C. 360bb(a)(2)). It describes FDA requirements and provides considerations for the use of various clinical trial designs and endpoints to generate clinical evidence to support product licensure. The recommendations are intended for sponsors developing CGTs intended for use in small populations to leverage the use of innovative trial designs to simultaneously expedite drug development and generate data necessary to demonstrate substantial evidence of effectiveness.
Learn More💊FDA Draft Guidance on Coccidioidomycosis Drug Development Available
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Disseminated Coccidioidomycosis: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of disseminated coccidioidomycosis caused by Coccidioides species (i.e., C. immitis and C. posadasii).
Learn More💊FDA Draft Guidance for sGERD Drug Development
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment." The draft guidance details FDA's recommendations on the clinical trials for drugs being developed for the treatment of symptomatic nonerosive gastroesophageal reflux disease (sGERD) in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
Learn More💊FDA Issues Draft Guidance for Developing Drugs for Erosive Esophagitis
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Erosive Esophagitis: Developing Drugs for Treatment." The draft guidance details recommendations on clinical trials for drugs being developed for the healing of erosive esophagitis (EE) and maintenance of healed EE in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
Learn More💊Catalent Pharma Solutions Controlled Substances Import Application Notice
Catalent Pharma Solutions, 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💊DEA Notice on Fisher Clinical Services' Importer Application
Fisher Clinical Services, Inc. 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 Final Guidance on E6(R3) Good Clinical Practice
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "E6(R3) Good Clinical Practice." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes a principles document and annex 1 and is the precursory guidance to the draft guidance entitled "E6(R3) Good Clinical Practice: Annex 2." Once complete, the guidance will be composed of a principles document, annex 1, and annex 2. The guidance is intended to outline flexible and modern good clinical practices for conducting clinical trials. Notably, the guidance highlights the importance of quality-by-design, proportionality, and risk-based approaches in conducting clinical trials to ensure safety and reliability of results. The guidance also encourages use of innovative design elements and technology in clinical trials, while avoiding unnecessary complexities. The guidance finalizes the draft guidance of the same title issued on June 7, 2023.
Learn More⚗️NIST to Establish Isotope Metallomics Quality Assurance Consortium
The National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce, in support of efforts to develop and evaluate measurement methods and reference standards, including reference materials, to support measurement quality and comparability for the isotope metallomics measurement community, is establishing the Isotope Metallomics Quality Assurance Program (IMQAP) Consortium ("Consortium"). The Consortium will bring together stakeholders to identify and address measurement and standards needs related to isotopic measurements of clinical/biological materials and products. The Consortium efforts are intended to advance measurement capabilities, provide measurement quality assurance strategies, support the development of clinical/biological matrix reference materials, and collect data to support the development of best practices and standard methods. Participants will be required to sign a Cooperative Research and Development Agreement (CRADA). At NIST's discretion, entities that are legally prohibited or not legally authorized to enter into a CRADA may be allowed to participate in the Consortium under an agreement other than a CRADA with terms that may differ, as necessary, from the CRADA terms.
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💊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.
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