The FDA proposes new guidelines for technological advancements in the pharma and healthcare arena, ensuring efficacy, safety and compliance in clinical trial procedures, biologics, new medical devices, high-risk medical devices, and AI-driven data.
These guidelines emphasize transparency, real-world evidence, risk mitigation, and safety profiling.
AI-Driven Decision-Making in Drug and Biological Product Submissions
AI models have been used in clinical trials for patient selection, predicting trial outcomes, optimizing study designs, drug repurposing, and patient stratification, directly influencing data analysis and decision-making.
Risk-Based assessment and Scientific Evidence
Sponsors must establish scientific evidence to demonstrate that an AI model’s output is credible and reliable for the intended context of use.
Early engagement- FDA encourages early engagement of the sponsors or manufacturers to-
- Align expectations on appropriate assessment activities based on model risk and context of use.
- Identify potential challenges and strategies to address them.
- Ensure compliance with post-marketing pharmacovigilance, where AI is used in safety surveillance, adverse event reporting.
In such cases, documentation is maintained per the sponsor’s standard operating procedures (SOPs) and provided to the agency upon request.
AI-Enabled Medical Devices: A New Era of Automation.
Medical devices have brought a revolution in healthcare, integrated with AI and machine learning offering rapid response, precision, analysis and remote accessibility.
The FDA proposed key considerations and recommendations for integrating product design, development, maintenance, and documentation to ensure efficacy and safety.
The FDA laid guidelines to address transparency and bias throughout the total product life cycle.
- Early Engagement – The FDA encourages sponsors to engage with the agency early and frequently to inform their activities throughout the device’s lifecycle, including planning, development, testing, and ongoing monitoring.
- Devices Upgradation – Recommends proactive planning and predetermined change in control plans for device updates already released in the market.
- Post-Market Performance – FDA recommends detailed description of post -marketing performance monitoring, management and risk mitigation for the AI-enabled devices in marketing submission.
- Risk Assessment – It provides specific recommendations to help sponsors demonstrate that they have addressed bias-related risks and offers suggestions for the thoughtful design and evaluation of AI-enabled devices.
- Informing Users – The guidance also details the type of information that should be communicated to users and the most effective methods for delivering that information.
- Addressing Supply chain vulnerabilities-The FDA recommends that stakeholders address vulnerabilities in the supply chain for medical devices. It advises informing the authorities in advance of any discontinuation or interruption in the manufacturing of medical devices to prevent disruptions in the supply chain.
Developing Drugs for Optical Imaging
These drugs are used in conjunction with imaging devices to enhance anatomical visibility of tumors or detect other pathological conditions. The FDA issues a blueprint for their design, excretion, and usage procedures to evaluate patient safety and clinical risks.
FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials
The FDA provides recommendations on biopsies, ensuring their safe and ethical use in clinical trials involving adults and children.
Evaluating the Need for Biopsy
Sponsors and researchers must ensure that the biopsy is necessary for the process or determine if it can be optional.
Informed Consent and Eligibility Criteria
- Ensure that the participants involved have the targeted medical condition for which the tissue sample is being taken.
- Participants should be informed about the biopsy procedure and its utility.
- The consent of the participant or, in the case of children, the parents or guardians, is highly required.
Risk Assessment
- This becomes more critical when involving children.
- It is essential to evaluate potential risks, including infection, bleeding, or any inflammatory response.
- The likelihood of any side effects occurring should be assessed.
The Role of Biopsies
- The primary and secondary endpoints should be clearly assessed.
- The significant contribution of the biopsy in the experiment should be evaluated.
Cell Therapies and Tissue-Based Products
The FDA laid emphasis on the scientific evidence on the use and development of cell therapies and tissue products like stem cells. The stakeholder is to provide real world evidence proving efficacy and advanced results.
The Bottom Line:
“Implementing Technology Responsibly to Secure the Future Healthcare Landscape.”
References:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-including-tissue-biopsies-clinical-trials