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FDA Regulation of Human Cell and TissueBased Products

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Transfusable blood products (already regulated by FDA) ... Approval of FDA Form 3356 for registration/listing. TAP and web pages ... – PowerPoint PPT presentation

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Title: FDA Regulation of Human Cell and TissueBased Products


1
FDA Regulation of Human Cell and Tissue-Based
Products
  • Jill B. DealInternational Regulatory Practice

2
Proposed Approach to Regulation of Cellular and
Tissue Based Products Reinventing the
Regulation of Human Tissue
3
WHY?
  • Regulation highly fragmented
  • No clearly defined criteria for product
    characterization industry confusion
  • Need for unified approach for old and new
    products
  • Need to permit flexibility and innovation

4
Tiered Risk-Based ApproachGoals
  • Prevent unwitting use of contaminated tissues
    with potential for transmitting infectious
    diseases, e.g., AIDS, hepatitis
  • Prevent improper handling or processing that
    might contaminate/damage tissues
  • Ensure clinical safety and effectiveness is
    demonstrated where highly processed tissues, used
    for other than their normal function, are
    combined with non-tissue components or used for
    metabolic purposes

5
Included
  • Products containing human cells or tissues or any
    component which is intended to be implanted,
    transplanted, infused or transferred into a human
    recipient
  • Musculoskeletal
  • Ocular
  • Cellular
  • hemapoietic stem cells
  • reproductive tissue
  • heart valves
  • dura mater

6
Not Included
  • Vascularized organs
  • Minimally manipulated bone marrow (both regulated
    by HRSA)
  • Transfusable blood products (already regulated by
    FDA)
  • Ancillary tissue-related products used in
    propogation, storage or processing or secreted
    from cells or tissues e.g., milk, collagen,
    urokinase, cytokines (already regulated by FDA)
  • Xenograft transplantation (regulated separately
    by FDA)

7
Concerns Direct Transmission of Communicable
Disease
  • Autologous v. allogeneic use?
  • Banked, shipped or processed in a facility
    handling cells or tissues from multiple donors?
  • Viable or non-viable tissue?
  • Obtained from a sexually intimate partner?
    (reproductive cells/tissues)

8
Concerns Processing
  • More than minimally manipulated? (Structural
    processing does not alter original
    characteristics of tissue or relevant biologic
    characteristics of cells or tissues)
  • Used for normal (homologous) function?
  • Combined with non-cell/non-tissue components?
  • Used for metabolic function?

9
Concerns Clinical Safety and Effectiveness
  • Same factors as processing concerns
  • May differ depending whether use is local,
    structural, reproductive or metabolic purpose
  • Stem cells subject to product, class specific
    controls and standards to be certified to See 63
    FR 2985 (Jan. 20, 1998)

10
Concerns Promotion and Labeling
  • cross cut all cells and tissue products

11
Proposed Approach Implemented by Tissue Action
Plan (March 1998)
  • Proposed Rule Establishment and Listing for
    Manufacturers of Cellular and Tissue-Based
    Products, 63 FR 26744 (May 14, 1998) (finalized
    Jan. 19, 2001)
  • Proposed Rule Suitability Determination for
    Donors of Human Cellular and Tissue-Based
    Products, 64 FR 52696 (September 30, 1999)
  • Proposed Rule Current Good Tissue Based
    Practices Inspection and Enforcement, 66 FR 1507
    (Jan. 8, 001)

12
Establishment Registration
  • 361 of PHS Act-prevent communication of
    transmissible disease
  • accrue and maintain basic knowledge of industry
  • permit communication with industry
  • register facilities, list products, keep
    information updated
  • all covered establishments

13
Included
  • Owners and operators of establishments or persons
    engaged in the recovery, screening, testing,
    processing or storage or distribution of human
    cellular or tissue based products

14
Exempted
  • scientific and educational purposes (solely)
  • autologous transferors
  • Carriers
  • facilities which receive or store solely for
    pending scheduled implantation, infusion or
    transfer within the same facility

15
Suitability Determination
  • 361 of PHS Act
  • all establishments covered by registration rule
  • 361 productsminimally manipulated means not
    promoted for any use other than homologous, not
    combined/modified with drug or device, no
    systemic effect and is for autologous use,
    family-related allogeneic use or reproductive use
  • 351 products-biologics, medical devices

16
Exempted from Testing Requirements
  • banked cells and tissue for autologous use
  • reproductive cells donated by a sexually intimate
    partner for reproductive use

17
GTP Rule
  • 361 of PHS
  • 361 products
  • 351 products (GTP requirements plus GMP and QS
    requirements)
  • proper handling, processing, storage, labeling,
    recordkeeping and establishment of a quality
    program

18
Goal of GTP Rule
  • No communicable disease agents
  • Not contaminated during manufacturing
  • Function and integrity of cells or tissues not
    compromised

19
Manufacture
  • Any or all steps in the recovery, processing,
    storage, labeling, packaging or distribution of
    any human cell or tissue product and the
    screening and testing of a cell or tissue donor

20
Responsibility under GTP Rule
  • Establishment responsible for making the product
    available for distribution
  • Considered and rejected assigning responsibility
    to each entity providing services

21
Range of Risks Establishes Degree of Regulation
  • No Regulation 361 Products
  • Autologous Transfer
  • Minimally manipulated products
  • 351 Products
  • BLA/PMA
  • More than minimally manipulated, non-homologous
    combination, metabolic

22
Other Activities To Implement TAP
  • Formation of Tissue Reference Group (TRG)
  • Purpose
  • Consider questions and make recommendations
    regarding jurisdiction, policy and regulations
  • Promote consistency in implementation of TAP
  • Request for Designation can be made to TRG or to
    FDA Ombudsman

23
Other Activities to Implement TAP
  • Workshops, FDA and FDA/NIH
  • Gene therapy letter (July 6, 2001), Cell Therapy
    Letter (coming soon)
  • Approval of FDA Form 3356 for registration/listing
  • TAP and web pages
  • Compliance Program on Inspection of Tissue
    Establishments
  • Guidance Program on Inspection of Tissue
  • Guidance for Industry on Availability of Licensed
    Donor Screening Tests Labeled for Use with
    Cadaveric Blood Specimens

24
Where are we now?
  • Suitability and GTP rules finalized by end of
    2002
  • Most gene therapy trials restarted
  • Development of a standard for adenoviruses
    (Williamsburg Bioprocessing Foundation)
  • Special office within CBER for human cell,
    tissue, gene therapy (October 2002)
  • FDA to issue guidance or regulations for stem
    cell products

25
Importance to Clients Developing Human
Cell/Tissue Products
  • Use of TRG to draft a meaningful regulatory
    strategy and, therefore, a meaningful business
    plan
  • Use flexibility of New Approach to obtain a lower
    degree of regulation by FDA (costs/time to
    market)

26
(No Transcript)
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