Overhaul on OCTGT Direction Improvement Program.

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2. FDA Good Guidance Practices (GGP). Guarantees legitimate improvement, arranging, handling, directing, and utilization of FDA direction archives Mandated by
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Overhaul on OCTGT Guidance Development Program Richard McFarland, PhD, MD Cellular, Tissue, and Gene Therapies Advisory Committee Meeting May 15, 2009

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FDA Good Guidance Practices (GGP) Ensures legitimate advancement, arranging, handling, steering, and utilization of FDA direction records Mandated by "Nourishment and Drug Administration Modernization Act of 1997" (FDAMA) Administrative Practices and Procedures; Good Guidance Practices," 21 CFR 10.115 CBER SOPP 8002 Annual Guidance Agenda distributed in Federal Register

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Guidance Documents arranged for FDA staff, candidates/supports, and people in general that: Describe the organization\'s elucidation of or strategy on an administrative issue; Relate to the preparing, substance, and assessment/endorsement of entries; Relate to the configuration, creation, fabricating, testing, naming, and advancement of controlled items;

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Other Documents Guidance archives do exclude archives identified with: Internal FDA systems; Agency reports; General data gave to purchasers or wellbeing experts; Speeches; Journal articles and publications; Media meetings and press materials; Warning letters; Memoranda of comprehension; Other interchanges or moves made by people at FDA or coordinated to individual people or firms; Documents coordinated at general wellbeing crises

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Guidance Documents Guidance records are planned to speak to our present intuition on matters talked about in the reports. CBER staff may leave from direction reports just with proper support and supervisory simultaneousness (21 CFR 10.115(d)(3)). Any predictable deviation from a direction record shows that we ought to overhaul it

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Level 1 Guidance Documents Federal Register reporting the accessibility of the draft direction for open remark Placed on CBER site FDA offers a remark period (normally 60 to 90 days) After assessing the general population remarks, CBER will change the direction Federal Register, declaring the accessibility of the last direction. The general population may submit remarks on the last direction whenever. CBER may issue a level 1 direction for prompt execution

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Level 2 Guidance Documents All direction archives not thought to be Level 1 Level 2 records put forward existing practices or minor changes in understanding or strategy

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Communication with the Public During Guidance Development When considering the improvement of direction CBER may unreservedly talk about issues with the general population. On the off chance that the issues to be tended to are especially mind boggling or disputable Holding an open meeting Holding admonitory board meeting on the issues Before drafting the direction Once arrangement of a draft direction report has been started Specifics of the direction are not examined with general society. At the point when the direction has been issued in draft Issues identified with the draft direction might be examined Issues identified with particular expectations in regards to the conclusion of the direction are not talked about 21 CFR 10.80 FDA may request data from people in general whenever amid the direction advancement process.

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Published Final Guidances (April 2008-May 2009) Content And Review Of Chemistry, Manufacturing, And Control (CMC) Information For Human Somatic Cell Therapy Investigational New Drug Applications (INDs) Final 4/2008 CTGTAC Discussions-Topics incorporated into examination at various gatherings Content And Review Of Chemistry, Manufacturing, And Control (CMC) Information For Human Gene Therapy Investigational New Drug Applications (INDs ) Final 4/2008 CTGTAC Discussions-Topics incorporated into exchange at various gatherings

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Published HCT/P Guidances (April 2008-May 2009) (cont\'d) Current Good Tissue Practices (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Draft-1/16/2009 Comment Period-Recently Closed CTGTAC Discussions-Implementation of Tissue Rule Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests Immediate Implementation-4/16/2008

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Published Donor Eligibility Guidances (Office of Blood Lead) (April 2008-May 2009) (cont\'d) Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products Draft-3/26/2009 BPAC Discussion-4/26/2007 Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft-4/25/2008 FDA Public Workshop Discussion-11/4/2002 Proposed RCDAD for HCT/P in DE direction Draft 5/2004 Final 8/2007

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Published Draft Guidances (April 2008-May 2009) Somatic Cell Therapy for Cardiac Disease Written by Cross-Center Cardiovascular Team (CBER-CDRH) Draft-4/2/2009 Comment Period-Closes 7/1/2009 CTGTAC Discussions-3/18/2004 Potency Tests for Cellular and Gene Therapy Products Draft-10/9/2008 Comment Period-Closed 1/7/2009 CTGTAC Discussions-2/9/2006

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CVM Guidance on Genetically Engineered Animals #187 - Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs Draft-1/15/2009 http://www.fda.gov/cvm/GEAnimals.htm

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CVM Guidance on Genetically Engineered Animals Covers all GE creatures with heritable rDNA builds (counting biopharm creatures, knockouts) Definition of "article" rDNA develop expected to influence the structure or capacity of the creature Case-by-case assessment Risk-based methodology Enforcement tact and endorsement ways NADA implies compulsory endorsement preceding promoting One existing endorsement

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Resources on the Web Consolidation of OCTGT directions Cellular and Gene Therapies http://www.fda.gov/cber/genetherapy/gtpubs.htm Tissues http://www.fda.gov/cber/tissue/docs.htm References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies (OCTGT) www.fda.gov/cber/genadmin/octgtprocess.htm

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Summary FDA direction procedure to speak with partners Good Guidance Practices (GGP) Governed by controls 21 CFR 10.115 OCTGT and CVM Recent Guidances Current Annual Guidance Agenda Additional Guidances to address issues emerging between Annual Guidance Agendas

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Conclusions OCTGT has a dynamic direction advancement program that incorporates Strategic Guidance Planning (Annual Agenda) Responds to changing needs OCTGT Guidance Program influences Input from CTGTAC gatherings Other open gatherings (NIH RAC, Workshops, Scientific Meetings, Industry Liaison Meetings) Cross-focus endeavors inside FDA Participation with Standards Development Organizations

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