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Combination Products CBER Report

Combination Products CBER Report. MDUFAMA Educational Seminar November 2002. Designation of Regulation of Combination Products. Achievements 1. Establish Office of Combination Products within 60 days 2. Prompt assignment of lead center 3. Timely and effective premarket review

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Combination Products CBER Report

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  1. Combination ProductsCBER Report MDUFAMA Educational Seminar November 2002

  2. Designation of Regulation of Combination Products • Achievements 1. Establish Office of Combination Products within 60 days 2. Prompt assignment of lead center 3. Timely and effective premarket review 4. Consistent and appropriate postmarket regulation 5. Timely and effective dispute resolution 6. Revision of guidance and agreements 7. Annual Report to Congress on activities

  3. Combination Office Functions • Establishes office within the Office of the Commissioner to ensure: • Prompt and Proper assignment to centers • Consult with Ombudsman’s Office on combinations • Timely and effective premarket review • Consistent/appropriate postmarket regulation • Development of guidances/clarifications of regulations • Serves as an “advocate” for combinations

  4. Timing and Structure of Office • To be established within 60 days (public meeting to be held Nov. 25) • To be headed by a director, staffed with appropriate scientific and medical expertise

  5. Office’s Role in Assigning Jurisdiction • Role in Premarket Review • Prompt assignment of primary jurisdiction for premarket review • Proper assignment (“primary mode of action”) of “agency center”.

  6. Combination Office’s Role in Ensuring Timeliness of Premarket Reviews • Will oversee timeliness of premarket review and coordinate reviews involving more than one center • Center of primary jurisdiction and consulting center/s are responsible to this Office for the timeliness of reviews • The Office will handle disputes involving timeliness, unless “clearly premarket”

  7. Combination Office’s Role in Ensuring Effective Premarket Review • Office will facilitate and coordinate reviews. Examples: • July SOP on consultative/collaborative process • “Awareness” reviews • October self-assessment report • For disputes involving substance, first reviewed by center with primary jurisdiction, under its dispute resolution procedures. Then, the Commissioner’s Office will handle, consulting with the Office of Combination Products.

  8. Office’s Role with Respect to Postmarket Requirements • Office will ensure consistency and appropriateness of postmarket regulations • “Consistent”: like products to be treated in like fashion • “Appropriate”: changes as necessary in accordance with applicable law. • Questions left unanswered (Nov. 35 hearing) • Reconciliation of like products • Consistency vs. Appropriateness • Definition of “like products”

  9. Office’s Role with Respect to Agreements, Guidances, Practices • Will review any agreement, guidance or practice specific to assignment of combinations to ensure consistency with 503(g)(4) • Will consult in this review with stakeholders and directors of centers. • May continue, modify or eliminate any agreement, guidance, or practice, and publish notice in Federal Register • Question: What is the true extent of this authority?

  10. Office’s Report to Congress • One year after date of enactment, and annually thereafter • Shall include: • Numbers and types of combo products reviewed and timeliness of assignments, reviews, and dispute resolutions • Number of reviews involving consulting center • Improvements in consistency of postmarket regulation of combo products

  11. Designation of Regulation of Combination Products • Achievements 1. Establish Office of Combination Products within 60 days 2. Prompt assignment of lead center 3. Timely and effective premarket review 4. Consistent and appropriate postmarket regulation 5. Timely and effective dispute resolution 6. Revision of guidance and agreements 7. Annual Report to Congress on activities

  12. Report on Certain Devices (a.k.a. CBER Report) • Report to Congress required within one year of enactment • Report will cover timeliness and effectiveness of device premarket reviews by centers other than CDRH

  13. CBER Report • Report contents: • Times required to log in and review original submissions and supplements • Times required to review manufacturers’ replies to submissions • Times to approve or clear such devices • Recommendations on any measures needed to improve performance, including allocation of additional resources

  14. CBER Report • Report will include recommendation on whether responsibility for regulating devices reviewed by other centers should be reassigned to”persons charged with regulating other types of devices” and whether transfer could have adverse impact on device safety and public health.

  15. Implications of Report • Authorship (preserving neutrality and independence) • Open products should not be transferred until report issued • Annual reports may be needed, depending on finding outcomes • Procedural vs. Substantial Expertise: Solutions to the public health issue

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