Drugs

CDER Small Business and Industry Assistance (CDER SBIA) Webinar – Pilot Clinical Outcome Assessment Compendium – March 8th, 2016

Image of SBIA Webinar 2016

 

The Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) is pleased to inform you of a unique opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.

These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

On March 8, 2016, CDER hosted a LIVE webinar titled: "Pilot Clinical Outcome Assessment Compendium (COA Compendium)

The pilot COA Compendium organizes and summarizes clinical outcome assessment (COA) information for many different diseases and conditions into a single resource and was recently published for public comment. FDA hopes the COA Compendium will ultimately foster patient-focused outcome measurement by facilitating communication with external stakeholders and providing clarity and transparency to drug developers and the research community. The COA Compendium is intended to be used as a starting point when considering how COAs might be utilized in clinical trials and will likely be most informative early in drug development.

This one hour webinar: 

  • Familiarized the audience with the recently announced pilot COA Compendium.
  • Addressed questions from the audience.

 

Our featured speakers were:
 
Elektra J. Papadopoulos, MD, MPH
Acting Associate Director, Clinical Outcome Assessments Staff (COA Staff),
Immediate Office
Office of New Drugs
Center for Drug Evaluation and Research
 
Nikunj B. Patel, PharmD
Clinical Outcome Assessment Reviewer, COA Staff,
Immediate Office,
Office of New Drugs,
Center for Drug Evaluation and Research
 
Paul Kluetz, MD
Associate Director,
Office of Hematology and Oncology Products,
Office of New Drugs,
Center for Drug Evaluation and Research
 
Christina Fang, MD, M.P.H.
Medical Officer, Division of Anesthesia, Analgesia, and Addiction Products,
Office of Drug Evaluation II,
Office of New Drugs,
Center for Drug Evaluation and Research
 
Andrew Mulberg, MD, FAAP, CPI
Deputy Division Director, Division of Gastroenterology and Inborn Errors Products,
Office of Drug Evaluation III,
Office of New Drugs,
Center for Drug Evaluation and Research
 

Please visit following websites for additional information:

 
 
 
 

 

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