Minutes of Institutional Review Board (IRB) Meetings
IRBs have been cited in Office for Human Research Protections and FDA Warning Letters for failing to prepare and maintain adequate minutes
- Minutes are missing
- Minutes reflect an inaccurate account of meeting attendance
- Minutes lack sufficient detail to show vote on actions
- Minutes are incomplete and only describe voting actions as “passed unanimously.”
- Minutes do not clearly indicate IRB approvals
- Minutes fail to include discussion of controverted issues
Minutes need to include:
- Attendance
- Actions taken
- Vote on Actions-for, against, abstaining
- Requiring changes or disapproving research
- Controverted issues and resolution
A Framework for Benefit-Risk Counseling to Patients About Drugs with a REMS
Additional risk management steps are required for certain prescription drugs with serious risks, to ensure that the benefits outweigh the risks
- Part of Risk Evaluation and Mitigation Strategy – REMS
- Additional steps include risk communications, patient‒provider agreements, patient counseling tools
- Warrant higher level of understanding of risks, greater degree of vigilance, activities to ensure benefits outweigh risks
- Require individualized and collaborative counseling approach
Proposed 4-E Framework
- Evaluate (and continuously re-evaluate): Individualized health profile, treatment goals, and counseling needs
- Educate: Treatment needs and options, potential risks and benefits, importance of adhering to REMS
- Engage: Patient participation in health care decisions and ensuring safe drug use
- Ensure: Patient counseling on key risk information and mitigation
Emerging Technology Program : Submission of chemistry, manufacturing, and controls (CMC) information containing emerging technology to FDA
- For IND, NDA, ANDA, DMF
- Support and enable pharmaceutical innovation and modernization
- Support flexible approaches to advance product design, modernize pharmaceutical manufacturing, improve quality
- Adopt innovative approaches by leveraging existing FDA resources to facilitate regulatory assessment of novel technology submissions
Discussion of Scope and Process
Classification of Products as Drugs and Devices & Additional Product Classification Issues
To address Requests for Designation (RFDs) whether a product should be classified as either a drug or a device
- RFD guidance on obtaining formal determination of product’s classification
- FDA’s decision-making process for classification determinations
Statutory Definitions
- Drug
- Device
Key provisions of Device definition
- “Similar or related article”
- “Primary intended purposes”
- “Chemical action”
- “Within or on the body”
- Illustrative Examples
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals
MDUFA IV authorizes user fees for De Novo classification requests
- Additional funds to improve the device review process
- Meet certain performance goals
- Implement improvements for device review process
FDA Actions
- Issue an Order Granting the Request to Classify the Device
- Issue an Order Declining the Request
- Request Additional Information (AI)
- Issue a Notice of Withdrawal
De Novo Performance Goals for MDUFA IV
- Submission
- FDA Review
- MDUFA IV Goals
- Missed MDUFA Decision Communication
Requester Actions
- Response to an AI Request
- Request for Withdrawal of the De Novo Request
Shortage of organs available for transplants has propelled innovation in organ preservation technologies
- Best practices for utilizing animal studies for the evaluation of organ preservation devices
- To support IDE, PMA, HDE, 510(k), De Novo applications/requests
Overview and General Study Design Considerations
- Procedure Duration
- Contamination
- Transportability
Reperfusion Models
- Ex Vivo Models
- In Vivo Models
Sample Panel of Biomarkers in Liver
- Liver Injury Biomarkers
- Liver Function Biomarkers
Image credit: FDA