More Talk, Less Work: US FDA Outlines Expectations For Combo Products Discussions
A new FDA draft guidance says manufacturers of combination products should first review existing combination product guidances and submit questions before asking for a combination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A new draft guidance document from the US agency offers nuts-and-bolts guidance on formatting Instructions for Use (IFUs) for drug-device and biologic-device combination product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.
On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporters Danny Al-Faruque and Sue Darcey about specific pieces of legislation that are expected to pass through the US Congress in the new year and how they’ll impact the medical device sector.