FDA News: ICH GCP Renovation, Medical Device Safety, Drug Development by Small Companies, Call for Advisory Committee Nominations – Drug and Device Digest

FDA BRIEF: Week of January 30, 2017

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ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6

The International Council for Harmonisation (ICH) Reflection Paper

  • FDA helped with draft
  • Focus on modernizing clinical trial design, planning, management and conduct
  • Addresses increasing diversity of study types and data sources used to support regulatory and health policy decisions
  • Underlying principles of human subject protection and data quality would remain

Revisions to:

  • ICH E6: Guideline for Good Clinical Practice
  • ICH E8 : General Considerations for Clinical Trials


 Registry-Based Prospective, Active Surveillance Of Medical-Device Safety

FDA funded study

PROBLEM: Medical Device Safety Assurance based constrained by reliance on voluntary reporting of adverse events

STUDY: Prospective, active surveillance of national clinical registry to monitor post-marketing safety of Mynx (Cardinal Health) implantable vascular-closure device

  • Had  suspected association with increased AE after percutaneous coronary intervention

METHOD: Used active clinical-data surveillance system –  DELTA (Data Extraction and Longitudinal Trend Analysis)

  • Integrated software components linking open-source database management and statistical analysis tools
  • Prospectively monitored clinical registries, detailed clinical-data sources


  • Rapidly identified potential safety signals among recipients
  • Initial safety alerts occurred within the first 12 months



Drug-Development Challenges for Small Biopharmaceutical Companies

Article co-authored by FDA and Sanofi Genzyme

Majority of drugs currently in development are  by small biopharmaceutical companies

  •  Virtual Companies (no products/revenue)  to  Small Companies (few commercial programs)

May have lower rate of success than that of large companies

  • Limited : Clinical development experience, infrastructure, manufacturing, resources and funding

Creative Approaches to Regulatory Success

  • Amazon : Amazon’s drug testing policy reflects its commitment to ensuring a safe and productive work environment. The company, known for its stringent policies, implements comprehensive drug testing procedures for its employees. Amazon conducts pre-employment drug screenings, random drug tests, and post-accident tests to maintain a drug-free workplace. This approach is particularly crucial given the intricate logistics and safety standards involved in its operations. By enforcing these measures, Amazon aims to safeguard both its employees and the millions of customers it serves daily, maintaining the integrity of its services while upholding its commitment to safety and responsibility.


Comments open through March 1, 2017


Collection of Nominations for Candidates To Serve on the FDA’s Advisory Committees

Nominee should provide:

(1) CV

(2) Written confirmation that the nominee is aware of nomination (unless self-nominated)

(3) Letters of Recommendation

Nominee should review:

  • Vacancies, Qualifications, and Experience
  • Potential Conflicts of Interest: Financial holdings, employment, research grants and/or contracts

Previous Metrics:

  • 2011: 638 submissions
  • 2012: 603 submissions
  • 2013: 622 submissions
  • 2014: 545 submissions
  • 2015: 357 submissions



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