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Next Steps For Interchangeable Biosimilars: Lifecycle Regulation Policy Development

 
• By Sue Sutter

US FDA seeks stakeholder views on manufacturing changes, new reference product indications and other questions that build on its draft guidance for approval of interchangeable biosimilars.

The US FDA is seeking stakeholder views on how it should regulate interchangeable biosimilars over their lifecycle, in conjunction with its new draft guidance on interchangeability.

The agency is requesting input on post-approval manufacturing changes and the impact of new reference product indications on a previously...

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US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
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UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
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The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

More from Compliance

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.