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The FDA published a new Draft Guidance on Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis.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FDA Draft Guidance on the risk of Bacterial Contamination of Blood Platelets
With a new draft guidance on the risk of bacterial contamination of blood platelets for transfusion purposes, the FDA wants to give updated recommendations on risk minimization to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In October 2018, the FDA published a new draft guidance with recommendations for a possible requalification of donors who had been deferred because of reactive test results for antibodies to Human T-Lymphotropic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".
FDA Guidance on Efficient Clinical Trial Design Strategies for Cancer Drugs and Biologics
Relating to the increasing need of simultaneously evaluatation of more than one investigational drug and/or more than one cancer type in one clinical trial, the FDA published a new guidance on Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.
GCP for ATMP - Stakeholder Consultation on the Draft Guideline
The European Medicines Agency had announced a guideline on GCP for ATMPs. Now, the Draft Guideline on Good Clinical Practice for Advanced Therapy Medicinal Products has been published and is open for targeted stakeholder consultation unti end of October.
The increasing Importance of Gene Therapies - FDA Statement and New Guidelines
The increasing importance of Gene Therapy becomes obvious when you take a look at the increasing focus of the competent authorities - as, for example, the current FDA's six new guidance documents on Gene Therapies show.
European Commission publishes revised Version of EU GMP Guideline Annex 2
As concequence of the adopted new regulations of GMP for ATMPs, the European Commission published a revised version of the Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use".