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Feedback on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial

by Emma Howlett | Jan 26, 2022

A cross collaboration of members participated in a series of meetings to review FDA Feedback on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial which was published for public...
Feedback on EMA draft toolbox guidance for PRIME marketing authorisation applications

Feedback on EMA draft toolbox guidance for PRIME marketing authorisation applications

by Emma Howlett | Oct 27, 2021

Regulatory Strategy members participated in a series of meetings to review EMA Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications which was published for public consultation...
Raw Materials: Supplier change notifications: change areas and requirements

Raw Materials: Supplier change notifications: change areas and requirements

by Emma Howlett | Jun 28, 2021

Change control and periodic re-assessment are an essential part of raw-material lifecycle management to maintain a qualified raw material. In addition, accurate and timely information is also required in risk assessment to identify any raw materials that warrant...

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