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FDA Science Board

FDA Science Board. Drug Safety Initiative April 15, 2005 Rockville, MD. RADM Steven Galson, MD, MPH Acting Director, Center for Drug Evaluation and Research Food and Drug Administration. Drug Safety – Change at FDA Outline. Dr. Crawford’s November announcement

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FDA Science Board

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  1. FDA Science Board Drug Safety Initiative April 15, 2005 Rockville, MD RADM Steven Galson, MD, MPH Acting Director, Center for Drug Evaluation and Research Food and Drug Administration

  2. Drug Safety – Change at FDA Outline • Dr. Crawford’s November announcement • Secretary Leavitt’s February announcement • What’s coming FDA SCIENCE BOARD

  3. Drug Safety – Specific Actions • Acting Commissioner Crawford’s 5-Point Plan Announced in November • Sponsor an Institute of Medicine (IOM) Study of the Drug Safety System • Implement a Program for Adjudicating Differences of Professional Opinion • Appoint Director, Office of Drug Safety • Conduct Drug Safety/Risk Management Consultations • Publish Risk Management Guidances FDA SCIENCE BOARD

  4. February Drug Safety Announcement – FDA Actions in 4 categories Overall goals: • promote a culture of openness and • enhanced oversight within the FDA Specific areas of change: • More outside expert consultations • Improve drug safety management practices • Change how we communicate about emerging drug risks to improve transparency • Continue our work to improve scientific methods of AE signal detection FDA SCIENCE BOARD

  5. Drug Safety Initiative • The initiative will: • Give patients, healthcare professionals and other consumers quick and easy access to the most up-to-date and accurate information on medicines. • Make FDA’s drug review, approval, and monitoring programs as transparent as possible. FDA SCIENCE BOARD

  6. Drug Safety Initiative • New drug safety information outlets • Proposed Drug Watch Program • Patient Information Sheets • Healthcare Professional Sheets • Drug Safety Oversight Board FDA SCIENCE BOARD

  7. Drug Safety Oversight Board • Drug Safety Oversight Board • Will provide independent oversight and advice to the CDER Center Director on management of: • Important drug safety issues and policies. • Dissemination of certain safety information through FDA’s website to healthcare professionals and patients. FDA SCIENCE BOARD

  8. Drug Safety Oversight BoardMembership • Chair – Deputy Director, CDER • Executive Director – Dr. Susan Cummins • Membership - representatives from relevant CDER offices, CBER, CDRH, NIH, VA. • Consumer or patient representatives and advisory committee members as consultants. • CDER is will make operating procedures available explaining the Board in more detail very soon. FDA SCIENCE BOARD

  9. Drug Safety Information – new steps • Proposed “Drug Watch” web page • List of drugs being watched • Patient information sheets • Physician information sheets FDA SCIENCE BOARD

  10. Summary • FDA responsive to concerns about drug safety decision making and communication • While comprehensive review underway, we will implement important changes to improve public knowledge, internal management and outside involvement • Changes will not be free of controversy and may raise important new issues for resolution FDA SCIENCE BOARD

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