Transmission of Malaria by Blood Donors - FDA updates Guidance Document
As a result of the specifics of the pandemic situation over the past two years, the FDA is issuing an update to its recommendations for reducing malaria transmission during transfusions. It replaces the April 2020 guidance.
FDA Information on bacterial Contamination of Platelets for Transfusion
After 2019 and 2021, the FDA will again update its findings and recommendations regarding bacterial contamination of platelet preparations for transfusion purposes.
ICH M10 Guideline on Bioanalytical Method Validation and Study Sample Analysis
The EMA published an updated Q&A document regarding the new ICH M10 guideline on Bioanalytical Method Validation and Study Sample Analysis. The document became effective on 21 January 2023.
ICH Q5 A (R1) Revision: Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
In October, the EMA published a revised version of "ICH: Q 5 A (R1): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin" for consultation.
Warning Letter in the Area of Allogenic Umbilical Cord and Amniotic Membrane Products
During an inspection at the end of 2021, the FDA identified a manufacturer of umbilical cord blood products as lacking approval as well as numerous deviations with regard to common GMP requirements.
CMC: FDA publishes Guideline with questions on post-approval modification of single-use materials
With the publication of a question and answer guideline, the FDA is responding to the challenges of the shortage of disposable materials in manufacturing and the requirements for the use of alternative materials in the area of chemistry, manufacturing and controls (CMC).
USP publishes Draft Guideline on Analytical Methods for mRNA Vaccines
At a time of increased interest in mRNA-based medicinal products and vaccines, the USP has published for comment a draft guidance document on "Analytical Methods for the Quality of mRNA Vaccines".
PharmEuropa - Revision of Chapter 2.6.30 Monocyte Activation Test
After the revision in 2017, the Monograph 2.6.30. Monocyte Activation Test in the European Pharmacopoeia undergoes a new revision which is open for comments until the end of June.
How to Demonstrate Comparability of Analytical Procedures
A new Ph. Eur. Chapter 5.27. Comparability of alternative analytical procedures has been proposed in Pharmeuropa 34.2. The comment deadline is 30 June 2022.
Revision of Chapter 2.6.7 of the European Pharmacopoeia published for Comment
After about 10 years, the EDQM has now published a draft revision of Chapter 2.6.7 on mycoplasma testing, which will be available for comment until the end of June.
FDA Guidance for Chimeric Antigen Receptor (CAR) T Cell Products
With a draft guidance for the development, manufacture and control of chimeric antigen receptor (CAR) T cell products, the FDA is expanding its recommendations for advanced biological products and providing further guidance to developers and manufacturers.
FDA revises Recommendations on Investigational COVID-19 Covalescent Plasma
The FDA has already updated its recommendations on handling plasma donations from COVID-19 diseased donors several times. Recently, a new update of the Guidance for Industry Investigational COVID-19 Convalescent Plasma was published.