Week of Nov 27, 2017
CDER Conversation: The FDA’s Sentinel Initiative
The Sentinel Initiative is national electronic system that monitors safety of marketed drugs, vaccines, biologics and medical devices
- Includes Active Risk Identification and Analysis (ARIA) system
- 17 data partners such as insurance companies, HMOs, and hospitals
- Access to 223 million members
- Data derived from administrative claims databases that healthcare insurers use for reimbursement for diagnoses, procedures, and medications
- Used as a resource for new product reviews
Sentinel System different from other systems
- Distributed data approach – data partners maintain physical and operational control over electronic data using Sentinel Common Data Model
- Secure access to multiple data sources to achieve far larger sample sizes
- Allow data aggregation while safeguarding patient privacy
- Routine Querying Tools
FDA, International Regulators Look at Common Challenges, ‘Innovation’
Global regulatory experts from 28 countries, including FDA, discussed ‘Innovation’ issues of mutual concern
- regenerative medical products
- international collaboration to fight antimicrobial resistance (AMR)
- developing strategies to combat substandard or falsified medical products
FDA presentations
- Use of real world evidence (RWE) in pre- and post-market activities
- Align their approaches to the evaluation of antibiotics
- Working with WHO in combating falsified/substandard medical products
- Need for international cooperation and increased sharing of inspectional results, collaborating on pharmacovigilance needs, and advancing regulatory science
PEPFAR: FDA Approves 200th HIV/AIDS Therapy
FDA tentatively approved the 200th antiretroviral drug application under the President’s Emergency Plan for AIDS Relief (PEPFAR)
- PEPFAR launched in 2003 to address global HIV/AIDS epidemic by stimulating development of new HIV therapies
- FDA used guidance, outreach and expedited review process
- FDA encouraged submission for single entity, fixed dose combination (FDC), and co-packaged versions of previously approved antiretroviral therapies
Advancements to facilitate treatment in areas of the world lacking advanced health care infrastructure, particularly in parts of Africa
- FDC even in circumstances with patent or exclusivity market protection for one or more of the components in the U.S
- Due to the significant public health impact of these products, FDA prioritized review
- Products purchased with U.S. funds under the President’s PEPFAR Fund
FDA ushering in new era of 3D printing of medical products
FDA has reviewed >100 3D printed devices currently on the market
- Patient-matched devices tailored to fit patient’s anatomy – knee replacements, implants
- Drug produced on 3D printer with more porous matrix
- Envision 3D printed new skin cells for burn wounds
State-of-the-art 3D printing facilities on FDA campus
- CDER scientists determine how 3D drug printing impacts manufacturing
- CDRH scientists investigate the effect of design changes on device performnace
- Understand policy framework to ensure quality and safety of 3D printed products
Providing comprehensive policy framework to manufacturers
- CDER’s Emerging Technology Program
- New guidance on technical aspects of 3D printing (additive manufacturing)
- Review regulatory issues related to bioprinting of biological, cellular and tissue-based product
Image credits: FDA, PEPFAR