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FDA panel: agency will look into improving access to petition records and confirms Orange Book contact point
Summary
Panelists acknowledged Regulations.gov can be difficult to navigate, said a historical list of suitability petitions exists but has not been updated, and provided the Orange Book email (orangebook@fda.hhs.gov) and guidance to use the current FDA form on the forms website.
Attendees asked whether FDA would update a consolidated list of approved suitability petitions on the agency website rather than relying only on Regulations.gov, which several participants described as hard to navigate.
Panelists said a log or database of suitability petitions existed at one point but had not been updated recently. The agency said it has received industry requests to improve access and "it's something that we are looking into," adding that case-specific inquiries can be sent to orangebook@fda.hhs.gov. On the topic of forms, an Orange Book staffer advised using the current version of the applicable FDA form on the FDA forms website even if it shows expired status.
Practical takeaway: applicants seeking records should email the Orange Book mailbox for assistance and show care when searching Regulations.gov; the agency acknowledged room for improvement in public access to petition records.
