More Talk, Less Work: US FDA Outlines Expectations For Combo Products Discussions
New FDA draft guidance says manufacturers of combination products should first review existing combination product guidances and submit questions before asking for a combination product agreement meeting with regulators to get clarification. The guidance outlines what is expected of both sides in such meetings.
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A new draft guidance document from the US agency offers nuts-and-bolts guidance on formatting Instructions for Use (IFUs) for drug-device and biologic-device combination product applications.
The meetings are tied to requirements from the 2016 21st Century Cures legislation. They could offer more development certainty for sponsors by allowing informal agreements with the agency on pre- and post-market issues.
The US agency’s device center on 26 October published its A and B lists of guidance documents it will prioritize in fiscal year 2022, including drafting guidances to transition emergency use authorized products to full marketing status, and finalizing a clinical decision support software guidance that’s been four years in the making.