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CBER - Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products

The FDA Center for Biologics Evaluation and Research (CBER) published the Guidance for Industy "Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products".

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FDA Guidances - Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products

Establishments that manufacture human cells, tissues, and cellular and tissue-based products have to comply with a number of requirements under Title 21 of the Code of Federal Regulations Part 1271 (21 CFR Part 1271). This includes Investigating and reporting adverse reactions.

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Human Cells, Tissues or Cellular- or Tissue-based Products - Exception from the Requirements under Part 1271

The US FDA published a draft guideline on Same Surgical Procedure Exception under 21 CFR 1271.15, related to human cells, tissues or cellular or tissue-based products. Read more here.

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FDA publishes Draft Guidance for Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products

The FDA has published a Draft Guideline with recommendations for human cells, tissues, and cellular- and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff  for the criterion of minimal manipulation. Learn more.

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NAT Testing of West Nile Virus from Human Cells and Tissues

As a part of their continuous review of new data related to West Nile Virus, the FDA published a Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Read more.

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Approval of combined Advanced Therapy Product

With a press release dated from 26 April, the European Medicines Agency (EMA) announced the CAT and Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of a combined advanced-therapy product. Read more.

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Risk-based Approach to Advanced Therapy Medicinal Products

In 2012, the EMA Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products was open for comments. The risk-based approach is based on the identification of various risks associated with the clinical use of an ATMP and risk factors inherent to the ATMP with respect to quality, safety and efficacy. To learn more about this, click here.

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EMA announces streamlining of activities of Committee for Advanced Therapies

To optimise the efficiency of EMA and the Committee for Advanced Therapies' in the field of ATMP, EMA has streamlined the activities of the CAT. More details here.

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Commitee for Advanced Therapy Medicinal Products (CAT) - Public Call for Expression of Interest

For membership in the Committee for Advanced Therapy Medicinal Products (CAT), the European Commisiion published a public call for interested representatives of patients' associates and clinicians. Read more here.

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ATMP - EMA Reflection Paper on Classification of Advanced Therapy Medicinal Products

Recently, the European Medicines Agency published an Reflection Paper on classification of advanced therapy medicinal products. This document is open for consultation until 31 July 2012. Read on.

 

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