FDA establishes New Advisory Committee on Digital Health Technology
A press release announced that this new committee shall advise the agency on issues related to complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. The advisory committee is anticipated to be fully operational next year.
Rare Disease Endpoint Advancement Pilot Program
The second round for applications is now open until 31 December 2023 for sponsors with an active investigational new drug (IND) or pre-IND for the rare disease, or sponsors who do not yet have an active development program but have, or are initiating, a natural history study where the proposed endpoint is intended to be studied.
This pilot program offers selected sponsors the opportunity for increased engagement with FDA experts from the Center for Drug Evaluation and Research and/or Center for Biologics Evaluation and Research.
Final Guidance Released
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (SPR-RMT)
This guidance describes a program at CBER for recognition of Voluntary Consensus Standards relevant to Regenerative Medicine Therapies and how CBER intends to review for recognition in the SRP-RMT.
Final Guidance Released
Benefit-Risk Assessment for New Drug and Biological Products
This guidance pertains to benefit-risk assessments made to support certain regulatory decisions about new drug applications (NDAs) or biologics license applications (BLAs), from premarket approval through the post-market setting and includes decisions regarding any regulatory requirements for approval, such as inclusion of a boxed warning in approved labelling, post-marketing study requirements and commitments, and risk evaluation and mitigation strategies.
Final Guidance Released
Prescription Drug and Biological Products - Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers - “Dose Banding”
Highlights FDA’s recommendations for incorporating information into proposed prescription drug labelling for injectable drug products based on weight or body surface, where the range of strengths is in ready-to-use containers and where the entire drug content of the container(s) is intended to be administered to a patient.
Draft Guidance Released for Comment
Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence
Here FDA describes factors to consider when assessing whether a single adequate and well controlled clinical investigation and confirmatory evidence are sufficient to demonstrate substantial evidence of effectiveness. The guidance also provides examples of types of data that could be considered confirmatory evidence and emphasizes the importance of early engagement with the Agency.
Submit comments by 18 December 2023
New Draft Guidance Open to Comments
Quality Considerations for Topical Ophthalmic Drug Products for solutions, suspensions, emulsions, gels, ointments, and creams. The guidance discussed quality considerations that are consistent with the current good manufacturing practice (CGMP) requirements.
Submit comments by 12 December 2023
Draft Guidance Released for Comment
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
This guidance describes how FDA request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, and at drug facilities covered under FDA’s bioresearch monitoring (BIMO) program.
Submit comments by 26 December 2023
Public Workshop - Request for Comments
Enhancing Adoption of Innovative Clinical Trial Approaches
FDA CDER is soliciting public comments on the state of innovation in clinical trial design and conduct, with the goal of better understanding the barriers and facilitators that both internal and external stakeholders face when trying to incorporate innovative clinical trial approaches in drug development programs. Responses will inform the programming for a hybrid public workshop, to be hosted on 19-20 March, 2024.
Good Machine Learning Practice (GMLP) for Medical Device Development: Guiding Principles
FDA, Health Canada and the MHRA jointly identified 10 guiding principles that can inform the development of GMLP, which supports the development of safe, effective, and high-quality artificial intelligence/machine learning technologies that can learn from real-world use and, in some cases, improve device performance. See related MHRA webpages.
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