In June 2024, the US Food and Drug Administration (FDA) issued a draft guidance for industry ‘Considerations for Demonstrating Interchangeability with a Reference Product: Update’ [1]. This draft g...
More >FDA interchangeable biosimilars guidance update on revised approach to switching studies
Guidelines/
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Posted 23/07/2024
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FORO LATINOAMERICANO DE ESTA SEMANA
An update on the joint EMA-HMA statement on interchangeability of biosimilar
Posted 12/05/2023
On 21 April 2023, the European Medicines Agency (EMA) and the Heads of Medicines Agenci...
Inflation Reduction Act explained
Posted 24/07/2023
The US Assistant Secretary for Planning and Evaluation’s (ASPE) ‘Medicare Part B drugs:...
Canada’s Prince Edward Island adopts biosimilars switching policy
Posted 07/11/2023
Canada’s Prince Edward Island (PEI) becomes the 11th Canadian jurisdiction to...
An update on the joint EMA-HMA statement on interchangeability of biosimilar
Posted 12/05/2023
On 21 April 2023, the European Medicines Agency (EMA) and the Heads of Medicines Agenci...
Inflation Reduction Act explained
Posted 24/07/2023
The US Assistant Secretary for Planning and Evaluation’s (ASPE) ‘Medicare Part B drugs:...
Canada’s Prince Edward Island adopts biosimilars switching policy
Posted 07/11/2023
Canada’s Prince Edward Island (PEI) becomes the 11th Canadian jurisdiction to...
Home/Non‐Biological Complex Drugs
FDA issues final guidance on liposome drug products
Posted 27/04/2018
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On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...
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