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BioTalk

1/30/2025 9:28:21 AM

New Policy for Compassionate Use Programs

By Hester Borgers Maud van Haaren

The Dutch Medicines Evaluation Board (MEB) has recently published a new policy for Compassionate Use Programmes (CUP).[1] To support the...

1/29/2025 11:15:40 AM

By Domien Op de Beeck Camille Vanpeteghem

On 23 December 2024, the Brussels enterprise court issued a first decision in Belgium on the so-called “SPC manufacturing waiver”. Under...

1/22/2025 11:28:54 AM

By Hester Borgers Maud van Haaren

On 9 September 2024 the European Medicines Agency (“EMA”) issued its final reflection paper on the use of AI in the medicinal product...

1/13/2025 11:15:48 AM

By Benedicte Mourisse Marc Martens

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have announced a significant update to their guidance on...