FDA News: FDA in India, TB Biorepository, Regulatory Science Progress Report, CDRH Accomplishments – Drug and Device Digest

FDA BRIEF: Week of March 27, 2017

Mary Lou Valdez with India Office Staff

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)


Liquid nitrogen tanks

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:

Biorepository websitedisclaimer icon.


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


cdrh report.JPGEstablish 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



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