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Policy Development and Guidance

This document outlines the current status and challenges in CMC guidance development under the FDA's oversight. Jon Clark, Associate Director for Policy Development, highlights the disconnection between existing guidance documents and contemporary scientific thought. He addresses the strengths and weaknesses in the guidance process and proposes a shift towards a more efficient model that integrates technical input from scientific teams. The emphasis on risk-based approaches and the potential formation of a Fact-Finding Group invites discussion on how to best align guidance with industry needs for improved product quality.

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Policy Development and Guidance

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  1. Policy Development and Guidance Jon Clark OPS Associate Director for Policy Development

  2. GMP for 21st Century • Some CMC guidance documents are out of synchronization with new thinking • Guidance process has strong and weak points • Strength is in technical input from staff scientists • Weakness is in decision making process for drafts

  3. Draft cycling CMCCC Body Review Teams CMCCC Body CMCCCWorking Group OPS Edit Legal Edit Public Comment

  4. Time Consuming Process • Rapid change in FDA thinking • Leaves slower efforts to “catch up” • Guidance development is a slower process • Investment of Time • Documents may be slow, but they have momentum • Guidance Content and New Direction are managed by different groups

  5. Actions Taken • Move coordinating and decision making from CMCCC working group to OPS Office • OPS Coordinating Committee (OPS CC) • Moves Guidance content management to OPS • Disband CMCCC • Mandate OPS CC to recruit technical input from scientists

  6. New Process Science input from selected Teams OPS CC OPS Edit Legal Edit Public Comment

  7. Synchronization Effort • Revision of drafts • Public comment recycle • Withdrawal of Documents • Mainly for finalized Guidance documents • Enforcement Discretion • Guidance to address regulation requirements

  8. Consider Options OTG • Other Than Guidance • Question and Answer Format • Post on public Internet • Keep it Simple • Manual of Policy and Procedure (MAPP) • If/Then format-Directed toward OPS staff • Publicly available • More rapid and flexible

  9. Guidance • Risk based approach • Reverse recent tendency toward proscription and prescription • Manufacturer chooses technology and approach to problem solving • Focus efforts on assurance of reliable product quality and not technology

  10. Input to Our Processes • What do you think? • Is there potential gain from formation of a “Fact Finding Group” to help us determine how we move toward the “Desired State?” • Do we need all the Guidances? • Where are they incongruent? • Provide advice as to what Guidance Industry needs as we work toward a new regulatory paradigm. • Prioritization

  11. End

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