The ISSCR Comments on the MHRA Consultation on Point of Care Manufacturing

The ISSCR submitted comments to the UK's MHRA on the Consultation on Point of Care Manufacturing that state, among other key points: We are particularly concerned that purveyors of autologous adipose-derived cell therapies might seek to exploit the regulations to sell adipose-derived cells for indications that they have not been shown to treat effectively. These therapies and all ATMPs should be preceded by well-regulated trials and testing that demonstrate the safety, efficacy, and quality of such products.

Read the comments.

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The ISSCR submitted comments on the CY 2022 Medicare OPPS and APC Proposed Rule