With an "Untitled Letter" the FDA addresses again a manufacturer of regenerative therapies that does not meet the appropriate requirements for marketing such a product.
The latest version (version 15) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for APIs was finalised and published on the APIC website in July 2021. It is also intended to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.
In October, the WHO published a draft revision of the Guide for the Safe Production and Quality Control of Monoclonal Antibodies. It is a continuation of the guidance documents on this topic that have already existed since 1991.
The GAO report details the number and frequency of FDA inspections of Covid-19 vaccine manufacturers and other biopharmaceutical manufacturers during the pandemic period.
By providing clarification on the designation "Regenerative Medicine Advanced Therapy" , the FDA is providing more clarity on which products may fall in this classification.
In an "Untitled Letter", the FDA requests information from a manufacturer of regenerative therapies based on umbilical cord stem cells on the approval status of the products distributed and used.
In order to take account of the rapid development in the field of biological medicinal products and ATMPs, the PIC/S has revised Annex 2 of its GMP Guideline and made it available for comment.
In December, the FDA updated its guidance on bacterial safety strategies for platelets and platelet preparations, particularly in light of the current implementation difficulties faced by facilities under pandemic conditions.
In January, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a revised version of its Aide Memoire "Inspections of Biotechnology Manufacturers".
As a complement to the many guidances and documents on the development and manufacture of products from human cells and tissues, the FDA also provides an overview of strategies and approved tests for microbiological testing of donors of cells and tissues.
