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GMP News

New FDA Draft Guideline regarding the Use of Human- and Animal-derived Materials

The FDA has published a new Draft Guideline on testing animal- and human-derived materials in the manufacturing of cell and gene therapy and tissue engineered medical products (TEMP). The FDA is asking for comments.

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EMA: Update of the Annex to the Excipients Guideline

In April 2024, the fourth revision of the "ANNEX: EXCIPIENTS AND INFORMATION FOR THE PACKAGE LEAFLET" of the guideline "Excipients in the labeling and package leaflet of medicinal products for human use" was published on the EMA website.

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EDQM: New Reference Standards available

The list of available reference standards is revised and published at regular intervals on the website of the EDQM. Five new substances have now been added to this list.

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