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The European Medicines Agency (EMA) proposes a revision of the Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells and published an corresponding concept paper incuding the current scientific developments.
The US FDA published Advisory on Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient.
Once again, the FDA has issued a Warning Letter to an Indian pharmaceutical manufacturer. The state of the manufacturing equipment and the missing validation of a tableting process were the main points of criticism. Find out more about the Warning Letter due to equipment deficiencies.