GMP News - Blood / Biologics and ATMP

04.08.15

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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18.06.15

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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18.06.15

Blood - Revised Recommendations for Reducing the Risk of HIV Transmission

With the new draft the US FDA wants to replace the guidance document "Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products," issued in 1992. Learn more about the draft Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.

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18.06.15

Biosimilars - Additional Q&A Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

The FDA issued additional Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 related to Biosimilars.

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21.05.15

FDA finalizes Guidelines for Biosimilars

The FDA issued the final version of three biosimilar guidance documents related to the BPCI Act from 2009. Read more about the Update of the Biosimilar Guidance Documents.

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19.03.15

Mixing, Diluting, or Repackaging Biological Products - FDA Draft Guidance

The US FDA published a draft guidance document on Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application. Read more about the FDA Draft Guidance.

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19.03.15

Revision of relevant PIC/S Guidance Documents in 2014

In 2014, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) published the revision of two annexes of their GMP guide, relevant  for blood and biological products. Read more about the Revision of relevant PIC/S Guidance Documents in 2014.

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19.03.15

Guidelines effective since end of 2014

Throughout 2014 several European Guidelines on biological drug substances and drug products were published and revised. Find out more about the Guidelines effective since end of 2014.

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19.03.15

FDA Outlook: Guidance Documents CBER is Planning to Publish in 2015

In January CBER published an overview about the planning of the development and teh revision of guidances in the field of blood, tissues and cellular products. Read more about the Guidance Documents CBER is planning on publishing.

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20.01.15

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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20.01.15

FDA finalizes Guidance for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

In December 2014, the Food and Drug Administration, Center for Biologics Evaluation and Research published the guidance on "Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture". Read more here.

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20.01.15

FDA Draft Guidance for initial testing for bacterial contamination of platelets published

With regard to Testing of Blood Platelets for Bacterial Contamination the US FDA has published a Draft Guideline. Read more here.

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20.01.15

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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11.08.14

EMA: Concept paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus

The European Medicines Agency (EMA) published a concept paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus and wants to organise a workshop to address the relevant issues. Read more.

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11.08.14

Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

The US FDA published a revised Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. Mere details can be found here.

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