Tag Archives: CBER

Drug Regulators, FDA, Publish Guidance for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood Intended for Hematopoiteic Reconstitution for Specific Indications

Posted on November 16, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Guidance for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood Intended for Hematopoiteic Reconstitution for Specific Indications

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The Center for Biologics Evaluation and Research (CBER), FDA, are recommending ways that would allow the manufacturer, generally a cord blood bank, to apply for licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood, for specified indications. This guidance document is intended to assist you in obtaining a biologics license. It contains information about the manufacture of minimally manipulated, unrelated, allogeneic placental/umbilical cord blood and how to comply with applicable regulatory requirements.
This guidance finalizes the draft guidance entitled “Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies,” dated December 2006.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, Publish Guidance for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood Intended for Hematopoiteic Reconstitution for Specific Indications

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Drug Regulators, FDA, Publish Draft Guidance on IND’s for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood

Posted on November 14, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Draft Guidance on IND’s for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood

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The Center for Biologics Evaluation and Research (CBER), FDA, are providing advice to potential sponsors (e.g., generally cord blood banks, or registries, and individual physicians serving as sponsor-investigators) to assist in the submission of an investigational new drug application (IND) for certain hematopoietic progenitor cells, cord (HPC-C), when such HPC-Cs are not licensed in accordance with 21 CFR 601, and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for treatment of a patient with a serious or life-threatening disease or condition and there is no satisfactory alternative treatment. If unlicensed HPC-Cs are made available for clinical use, they must be distributed under an IND meeting the applicable requirements in 21 CFR Part 312.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, Publish Draft Guidance on INDs for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood

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Drug Regulators Publish Draft Clinical Guidelines for Cancer Vaccines

Posted on October 26, 2009 by admin| Leave a comment

Drug Regulators, FDA CBER, Publish Draft Clinical Guidance for Cancer Vaccines.

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This guidance provides sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine, recommendations on critical clinical considerations for investigational studies of these products. This guidance will discuss considerations common to phase 1 and phase 2 clinical trials (which collectively may be referred to as “early phase clinical trials”) and phase 3 clinical trials (which may be referred to as “late phase clinical trials”) and that are unique to specific stages of clinical development of these biological products.
The products discussed in this guidance are for therapeutic cancer vaccines, referred to as “cancer vaccines” throughout this document, intended to be administered to patients with an existing cancer for the purpose of treatment. This guidance does not apply to products intended to be administered to patients to prevent or decrease the incidence of cancer. Furthermore, this guidance does not apply to adoptive immunotherapeutic products such as T cell or NK cell products. Although clinical trials involving these products share certain overlapping features with those involving cancer vaccines, adoptive immunotherapeutic products have different mechanisms of action and unique requirements with respect to product development.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators Publish Draft Clinical Guidelines for Cancer Vaccines

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Parallel Scientific Advice at the Regualtors

Posted on October 19, 2009 by admin| Leave a comment

FDA and EMEA have a Parallel Scientific Advice Procedure – Reminder

Just a reminder that the FDA CBER (centre for biological evaluation and research) and EMEA have a combined scientific advice procedure. It is a pilot programme at the moment and is developed to offer a parallel process to industry.

On September 17, 2004, the EMEA and the FDA agreed to undertake a pilot program to provide parallel scientific advice (PSA). The pilot began on January 1, 2005 and was extended per agreement of both parties on March 13, 2006. For the FDA, this program aligns most closely to pre-IND/end of Phase II meetings. During this pilot, PSA efforts should focus primarily on important breakthrough products. The expected advantages from such interactions are.

  • increased dialogue between the two agencies and sponsors from the beginning of the lifecycle of a new product,
  • a deeper understanding of the bases of scientific advice, and
  • the opportunity to optimize product development and avoid unnecessary testing replication or unnecessary diverse testing methodologies.

These meetings are conducted under the auspices of the confidentiality arrangement between the European Commission, the EMEA, and FDA. The complete text of the agreed upon general principles for the pilot can be found at the General Principles EMEA – FDA Parallel Scientific Advice Meetings Pilot Program website.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Parallel Scientific Advice at the Regualtors

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Biological Regulators Provide Guidance on Submission of Lot Release Protocols

Posted on September 30, 2009 by admin| Leave a comment

FDA, CBER, Publish Guidance on Providing Regulatory Submissions in Electronic Format – Lot Release Protocols

The Center for Biologics Evaluation and Research (CBER), are issuing this guidance under 21 CFR 601.14(a) to assist you, manufacturers of biological products regulated by CBER, in submitting lot release protocols in electronic format to CBER’s Product Release Branch. This guidance supersedes the guidance of the same title dated July 2006. We are updating this guidance to delete references to 3.5 inch diskettes due to changes in technology that are phasing out the use of this type of electronic format.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
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Drug Regulators Publish Draft Guidance on E16 Genomic Biomarkers Related to Drug Response

Posted on September 28, 2009 by admin| Leave a comment

FDA CBER Publish E16 Genomic Biomarkers Draft Guidance: Context, Structure and Format of Qualification Submissions

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The guideline describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers, as defined in ICH E15. Biomarker qualification has not been covered in any ICH guideline. Qualification is a conclusion that the biomarker data submitted support use of the biomarker in drug discovery, development or post-approval and, where appropriate, in regulatory decision-making. The objective of the guideline is to create a harmonized structure for the qualification of genomic biomarkers that will foster consistency of applications across regions and facilitate joint discussions with and among regulatory authorities. It is also expected that the proposed document format will, where appropriate, facilitate incorporation of genomic biomarker data into specific product-related applications. Biomarker qualification can take place at any time during drug discovery, development or the post-approval period. For those instances where it is appropriate, general guidance for inclusion of biomarker qualification data into the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) format marketing authorization applications is provided in this document. The use of the CTD format would be expected when biomarker data are submitted as part of an NDA or MAA or upon request by the regulatory authorities.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators Publish Draft Guidance on E16 Genomic Biomarkers Related to Drug Response

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Posted in clinical, pre-clinical, regulatory

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Drug Regulatos, FDA, Reppost Guidance on CMC Submissions for Therapeutic Recombinant DNA-Derived Products or Monolconal Antibody Products

Posted on September 14, 2009 by admin| Leave a comment

The FDA has re-posted guidance first published in 1996 “FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION FOR A THERAPEUTIC RECOMBINANT DNA-DERIVED PRODUCT OR A MONOCLONAL ANTIBODY PRODUCT FOR IN VIVO USE”

This guidance provides a section by section description of the Chemistry, manufacturing and control section of an FDA submission, its aimed specifically at Specific Biotech products, but should be considered by other related technologies. There is no apparent reason for the re-posting but it could be the FDA is planning an update.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulatos, FDA, Reppost Guidance on CMC Submissions for Therapeutic Recombinant DNA Derived Products or Monolconal Antibody Products

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