FDA BRIEF: Week of January 30, 2017


Image result for ICH logo

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

READ


 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

RESULTS:

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

READ


nejm

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

Figure

Comments open through March 1, 2017

READ


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

READ


 

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s