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.
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).
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With a draft guidance for the development, manufacture and control of chimeric antigen receptor (CAR) T cell products, the FDA is expanding its recommendations for advanced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.