Organs-On-Chips for Radiation Countermeasures
Organs-on-chips mimic the structure, function, interactions between living tissues within human organs on chips
Use for development of medical countermeasures (MCMs)
- Develop models of radiation damage in lung, gut, and bone marrow organs-on-chips
- Use models to test candidate medical countermeasures to treat such damage
Understand how sex differences impact body’s response to MCMs for radiological and nuclear preparedness
- Assess differences in sex-specific responses to radiation exposure and chemotherapeutic agents
- Effect of MCMs on that response in the bone marrow chip
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements
Recent research on Direct-to-consumer (DTC) promotional labeling/advertisements for prescription and OTC drugs indicates
- Consumers can recall and comprehend efficacy and risk information when it is provided quantitatively
- Quantitative information can improve consumers’ accuracy in estimating the drug’s benefits and risks
Recommendations for presenting quantitative efficacy and risk information in DTC promotional materials:
- Probability information in terms of absolute frequencies, percentages, and relative frequencies
- Formatting quantitative efficacy or risk information
- Using visual aids to illustrate quantitative efficacy or risk information
- Providing quantitative efficacy or risk information for the treatment group and the control group
CDER Scientists Investigate Critical Cellular Functions That Can Be Targeted to Kill Cancer Cells
Scientists in the CDER Office of Pharmaceutical Quality studying biochemical reactions of cancer cells to certain drugs designed to penetrate mitochondria
- Mitochondria are “powerhouses” of the cell
- Drugs that selectively enter and damage the mitochondria of cancer cells are of interest
- However, cancer cells may thwart this strategy by employing a multi-step process, called mitophagy
- Understand how removal of damaged mitochondria by mitophagy contributes to drug resistance during chemotherapy
FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership
FDA and Dept of Homeland Security (DHS) signed memorandum of agreement to implement a new framework for addressing cybersecurity in medical devices
- DHS will continue as central medical device vulnerability coordination center
- DHS will continue to coordinate and enable information sharing between medical device manufacturers, researchers and the FDA
- FDA will continue to engage with DHS and advise DHS regarding the risk to patient health and potential for harm posed by identified cybersecurity threats and vulnerabilities
Draft Recommendations on Premarket Submissions for Management of Cybersecurity in Medical Devices
Provide recommendations regarding cybersecurity device design, labeling, and documentation for devices with cybersecurity risk
- General Principles & Risk Assessment
- Designing a Trustworthy Device: Application of NIST Cybersecurity Framework
- Labeling Recommendations for Devices with Cybersecurity Risks
- Cybersecurity Documentation
- Recognized Standards
FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies
Focus on modernizing approach to design of clinical trials, making drug development process efficient and less costly, while maintaining regulatory standards
- New pilot program to encourage use of complex innovative trial designs, particularly in areas with small patient populations or unmet need
- Use of master protocols in oncology trials and one on the use of adaptive designs for clinical trials
Two new guidances
- Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment
- Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease
- Part of FDA’s science-based mission to modernize clinical trials and advance the development of safe and effective drugs and biologics for American public
Fall 2018 Unified Agenda: FDA’s New Regulatory Work to Advance Health and Safety
Federal government published Fall 2018 Unified Agenda, on government’s top regulatory priorities including FDA priorities
- Combating Nicotine Addiction and Preventing Use among Youth
- Modernizing Nutrition Claims, Labels and Standards of Identity
- Prioritizing Medical Device Innovation and Safety
- Advancing Drug Safety, Accessibility and Affordability
Image credit: FDA