Industry Proposes Its FDA Guidance Priorities, Reforms
This article was originally published in The Gray Sheet
After FDA published its annual lists of guidance priorities, industry has responded by stating what guidances companies would like to see. Meanwhile, the push for broader reforms to the guidance-development process continues.
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The device center has committed to metrics for draft guidance documents, trying to address complaints that policies linger too long in the draft stage and create regulatory confusion. CDRH also highlighted recent website upgrades intended to better distinguish between draft and final guidance documents.
Device industry advocates stressed to CDRH during a meeting last week that draft-guidance documents need to more routinely be finalized or withdrawn in an expedited manner, and that agency staffers must resist using the out-for-comment document as if they are settled policy.
FDA’s device center will seek feedback on its guidance development process and best practices at a June 5 workshop.