Industry
Cell Therapy Industry LinkedIn group
The LinkedIn Cell Therapy Industry group was created to serve as a network of those in the regenerative medicine industry and cell therapy sector. The group is intended to act as a vehicle for referrals, networking, sharing info, and facilitating collaboration. It will also support the activities and interaction of the ISCT Cell Therapy Commercialization Committee (see below right).
To learn more about and join the LinkedIn Cell Therapy Industry group, follow this link.
www.linkedin.com
Timely Industry-Related Information
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FDA has issued a new draft guidance entitled
"Somatic Cell Therapy for Cardiac Disease"
The
guidance is intended to provide sponsors who are developing cellular
therapies for the treatment of cardiac disease, with recommendations on
the design of preclinical and clinical studies, and on the chemistry,
manufacturing, and controls (CMC) information to include in an
investigational new drug application (IND) for cardiac cellular therapy.
This guidance provides to sponsors developing cellular therapies for the treatment of cardiac disease with recommendations including, but not limited to, the following: (1) Design of preclinical and clinical studies; (2)
information to submit on the product delivery system; and (3) the chemistry, manufacturing and controls information to include in an IND for cardiac cellular therapy. This guidance also includes regulatory considerations for the use of intravascular catheter delivery systems including recommendations regarding the information that sponsors should submit on the product’s delivery system.
This guidance provides to sponsors developing cellular therapies for the treatment of cardiac disease with recommendations including, but not limited to, the following: (1) Design of preclinical and clinical studies; (2)
information to submit on the product delivery system; and (3) the chemistry, manufacturing and controls information to include in an IND for cardiac cellular therapy. This guidance also includes regulatory considerations for the use of intravascular catheter delivery systems including recommendations regarding the information that sponsors should submit on the product’s delivery system.
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Notice to HCT/P Establishments: FDA Form 3356 Annual Tissue Establishment Registration/Listing – 2008
Please be advised that FDA will not be mailing the annual registration form to establishments that register electronically. A reminder announcement will be sent to the email address of the reporting official. Additional information to assist you in submitting your annual registration:
- All establishments are required to submit annual updates to FDA between November 15 and December 31, 2008 regardless of changes. Do not send to FDA before November 15.
- FDA Form 3356 has been revised. Changes under Part II for listing include:
- Infectious disease test laboratories: We have deleted the “No HCT/P Specified” row. The reason for doing this is that per 1271.25(b)(c) your HCT/P listing must indicate the HCT/P for which you perform this manufacturing function. When listing the HCT/P's recovered from the donors you test, please do so to the best of your knowledge.
- Additional HCT/Ps: On the new form all additional HCT/Ps that you previously added to the listing have been deleted. Please see the attached information with revised instructions at http://www.fda.gov/cber/tissue/tisrevinstr.htm for listing other HCT/Ps. If you are registering electronically using eHCTERs there is a new drop down menu for listing these HCT/Ps that are not printed on Form FDA 3356 and not otherwise listed in eHCTERs. Additional instructions are also included in eHCTERs.
- Establishments must provide a legal name of the establishment in Box 4. Legal names should not be an individual's first and last name. Please modify your registration if you have indicated an individual's first and last name in Box 4.
- Establishments that only match reproductive donors (e.g., oocytes, or embryos) with a recipient and do not perform the donor screening interview of record that will be used to make the donor eligibility determination should inactivate their registrations (check Box 2d).
- FDA encourages you to return your annual registration by electronic submission through a secure web page at http://www.fda.gov/cber/tissue/tisreg.htm.
Questions can be addressed to Rosemarie Wiseman 301-827-6176 or email tissuereg@fda.hhs.gov.
Additional information concerning tissue establishment registration and product listing can be found at www.fda.gov/cber/tissue/tisreg.htm.
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Publication of Fourth Edition Cellular Therapy Standards
The fourth edition of the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration is officially published and will be effective on January 29, 2009.
The Standards and the accompanying Accreditation Manual can be purchased or downloaded for free from this website. The Inspection and Document Checklists have been completed and will be used for documenting compliance with the new Standards.
Resources have been updated to assist cellular therapy programs with the transition from the third edition to the fourth edition.
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Guidance for Industry. CGMP for Phase 1 Investigational Drugs.
http://www.fda.gov/Cber/gdlns/indcgmp.htm
http://www.fda.gov/Cber/gdlns/indcgmp.htm
This guidance applies to investigational new drug and biological products (including finished dosage forms used as placebos) intended for human use during phase 1 development that are subject to CGMP requirements of section 501(a)(2)(B) of the FD&C Act, and are excluded from complying with the CGMP regulations in 21 CFR part 211, by operation of 21 CFR 210.2(c). These include but are not limited to:
* Investigational recombinant and non-recombinant therapeutic products
* Vaccine products
* Allergenic products
* In vivo diagnostics
* Plasma derivative products
* Blood and blood components6
* Gene therapy products
* Somatic cellular therapy products (including xenotransplantation products).
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The DRAFT United States Industry Consensus Standard for the Uniform Labeling of Cellular Therapy Products using ISBT 128, Version 1.0.0 is the result of the collaborative efforts of AABB, ASBMT, ASFA, FACT, ICCBBA, ISCT, and NMDP.
It is available for comment until August 1, 2008.
All comments will be taken into consideration prior to the final publication of the document. The document may be found at: http://www.iccbba.org/documents/usctcs.pdf
Comments should be sent to ctcomments@iccbba.org
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Important New FDA Guidance Document Available for Comment: Considerations for Allogeneic Pancreatic Islet Cell Products
In May 2008, the FDA announced the release of the Guidance Document, Guidance for Industry, Considerations for Allogeneic Pancreatic Islet Cell Products.
The FDA is accepting public comment to this draft guidance until August 20, 2008. The ISCT is facilitating the comment process by collating and submitting comments to the FDA guidance on behalf of the cell therapy sector.
Please submit your comments to Audrey Le at audrey@celltherapysociety.org by August 13, 2008.
Instructions for submitting comments to ISCT.