FDA issues Warning Letter to Manufacturer of Human Cells, Tissue or Cell based Products
The FDA has published a Warning Letter to a manufacturer of umbilical cord blood products for therapeutic use in humans due to deficiencies in the classification and manufacture of the products.
Updated Information about the Risk of ZIKA Virus Transmission via Cells and Tissues
Based on the updated information from the CDC, the FDA pointed out the current risk assessment for the transmission of Zika virus through blood, cell or tissue products at the end of February.
Monographs on Vaccines and Immunosera - Revised Expert Guidance
During its 162th session, the European Pharmacopoeia Commission published the revised guideline "Guide for the elaboration and use of monographs on vaccines and immunosera for human use", which helps experts and interested parties in this field to prepare and interpret the monographs.
Test for bacterials Endotoxin - New EP Chapter on recombinant Factor C open for public Comments
The European Commission and the EDQM have published a new chapter of the European Pharmacopoeia for testing bacterial endotoxins with recombinant factor C (rFC) for public comment.
FDA Guideline on Immunogenicity Testing of Therapeutic Protein Products published
In January, the FDA published a guide on immune responses to protein products: "Immunogenicity testing of therapeutic protein products - Development and validation of assays for the detection of antidrug antibodies".
Gene Therapeutics - FDA updates Requirements for CMC Information
In recent months, the FDA has published a number of documents on gene therapy. With a draft guideline on "Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)", the next step in the update of the relevant guidelines has been taken.
Transfusion Transfer of Babesiosis - FDA Draft: Recommendations for Risk Minimization
The FDA published a new Draft Guidance on Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis. The recommendations contained in this guidance apply to the collection of blood and blood components, except source plasma.
FDA Draft Guidance on the risk of Bacterial Contamination of Blood Platelets
With a new draft guidance on the risk of bacterial contamination of blood platelets for transfusion purposes, the FDA wants to give updated recommendations on risk minimization to affected donor institutions and transfusion centers.
Products with Genetically modified Cells - Draft Guideline
Due to the ongoing scientific development of laboratory methods, the EMA published a draft revision of their "Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells" for public consultation.
False Positive HTLV Testing - Recommendations for Donor Requalification
In October 2018, the FDA published a new draft guidance with recommendations for a possible requalification of donors who had been deferred because of reactive test results for antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II). Read more about the requalification method under 21 CFR 610.41.
Viral Safety of Blood and Plasma - FDA Guidance on HCV Testing
FDA published their recommendations for further testing if the result of a donor screening test for antibodies to the hepatitis C virus (anti-HCV) came out positive. These recommendations may be found in the draft guildeline on "Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus".