FDA Guidance on Promotional Labelling and Advertising for Biologicals, Biosimilars and Interchangeables

Guidelines/ | Posted 28/05/2024 comments 0

The US Food and Drug Administration (FDA) announced on 24 April 2024, the availability of a revised draft guidance for industry entitled ‘Promotional Labeling and Advertising Considerations for Pre...

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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...

Regulation V13H16
Inflation Reduction Act explained
Posted 24/07/2023

The US Assistant Secretary for Planning and Evaluation’s (ASPE) ‘Medicare Part B drugs:...

Switching V19A17
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
Liposome V15L11

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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