FDA BRIEF: Week of March 27, 2017
FDA In India- Championing a Culture of Quality
By: Mary Lou Valdez is FDA’s Associate Commissioner for International Programs
India and FDA:
- 7th largest supplier of food, 2nd largest supplier of pharmaceuticals and biologics to US
- Agency’s office in New Delhi conducts inspections and trains Indian medical products and foods facilities
- Collaboration with Indian regulatory counterparts – Indian Export Inspection Council (EIC), Food Safety Standards Agency of India (FSSAI), Drugs Controller General of India (DCGI), and Joint Secretary of the Ministry of Health and Family Welfare
- Participation in Global Food Safety Partnership (GFSP) Governing Council meeting and the Indian Pharmaceutical Alliance (IPA) Forum
Common Theme:
- Collaboration to enhance regulatory effectiveness and advance risk-based, science-based approaches to regulation
- Allow India to engage with International Council for Harmonisation (ICH) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S)
Tuberculosis Biorepository Aims To Bolster TB Drug Development by Facilitating Research on Biomarkers
By: Leonard Sacks, M.D., Associate Director for Clinical Methodology, Office of Medical Policy, CDER
TB Biorepository:
- Secured CTB2 TB Biorepository facility managed by Fisher BioServices, Bishops Stortford, Hertfordshire, UK
- State-of-the-art quality monitoring and full backup systems
- Receives funding from the National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation
- Collaboration with TB Alliance, the TB Trials Consortium within the Centers for Disease Control and Prevention, and the AIDS Clinical Trials Group
- Works to overcoming obstacles to identifying TB Biomarkers
- Can provide qualified investigators with complete, well-categorized biospecimens to develop or validate potential biomarkers
FY 2015-2016: Regulatory Science Progress Report
- Advancing the science of medical product development and evaluation: Non-clinical predictive models, drug carcinogenic effects, computational phantoms for devices, genetic and transplantation approaches to create predictive animal models
- Improving Clinical Evaluation: Foster biomarker development and adoption, guide treatment decisions and predict disease progression
- Advancing product manufacturing and quality: Computational capability for studying continuous manufacturing, advanced process control system, predicting critical properties of human stem cell preparations
- Ensuring the safety and effectiveness of marketed medical products: National electronic system for active medical product surveillance, Sentinel system, National Evaluation System for health Technology (NEST)
- Advancing regulatory science to promote global health: Responses to Ebola, Zika, pandemic influenza virus
- Infrastructure and organizational changes to advance regulatory science: Enhanced IT for regulatory application reviews, organizational and programmatic changes to address regulatory science issues, enhance scientific interactions with stakeholders, industry engagement with guidance documents, workshops
Establish a National Evaluation System for Medical Devices:
- Establish the National Evaluation System for health Technology (NEST)
- Develop a framework for the incorporation of real-world evidence into regulatory decision making
Partner with Patients:
- Patient Engagement Advisory Commitee
- Education and Training
Promote a Culture of Quality and Organizational Excellence:
- Quality Management Framework
- Education and Training
- Case for Quality
- Voluntary Programs