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.
FDA publishes Draft Guidance for Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products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.
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.
Uniform Blood and Blood Component Container Labels
After a request of the International Council for Commonality in Blood Banking Automation, the FDA published a Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels. Get more details.
Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products
Related to the necessary assessment of environmental impacts, the FDA published a Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products. Read more here.
New Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
On 6 March, the CBER published a new guideline for Industry as well as for FDA staff related to the Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood.
A new era has begun with the publication of the draft on the revision of Annex 15 (Validation/ Qualification) with regard to validation. The volume has grown from 11 to 17 pages. A few new chapters have been added, whereas much familiar information is missing. You will find a detailed analysis in the News.
Good Practice Guidelines for Blood Establishments as a Co-Operation between the EDQM/CoE and the EU Commission published
The EDQM and the Commission of the European Union published "Good Practice Guidelines for Blood Establishments and Hospital Blood Banks Required to Comply with EU Directive 2005/62/EC”. Read more here.
The Active Substance Master File (ASMF) describes the quality of an API and is an essential document for the marketing authorisation of medicinal products. The procedure to submit an ASMF has been recently updated and described extensively in a new EMA Q&A document. Read more about the newest provisions.