In addition to the publication of a large number of guidelines and supporting documents in the field of cell and tissue products, the FDA also provides insights into the biological research projects of its scientists on its website.
Due to the great public interest and the varied discussions, EMA organises a public meeting on Covid-19 vaccines and the role of EMA in the approval process, which all interested citizens can attend via live broadcast.
In the currrent times of controversial discussions many biopharmaceutical manufacturers are dealing with the question what test is best suitable for endotoxin and pyrogen testing.
Ende Juli hat die FDA (CDER) einen Leitfadenentwurf zur Festlegung von Endotoxin-Grenzwerten während der Entwicklung von Arzneimittel für die Onkologie und Biologische Produkte veröffentlicht.
By providing information on the safety of cell and tissue products in relation to coronavirus, the FDA gives support in questions of transferability by donors.
Testing for virus contamination plays an important role in blood and blood components. Recently, the FDA has published a guidance document on testing for T-lymphotropic viruses by means of serological testing.
