https://www.fda.gov/regulatory-information/search-fda-guidance-documents/public-availability-advisory-committee-members-financial-interest-information-and-waivers
https://archive.ph/kcMTx
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Guidance for the Public, FDA Advisory Committee Members, and FDA
Staff: Public Availability of Advisory Committee Members' Financial
Interest Information and Waivers1
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking
on this topic. It does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. You can use an alternative approach if the approach
satisfies the requirements of the applicable statutes and regulations. If you want to
discuss an alternative approach, contact the appropriate FDA staff. If you cannot
identify the appropriate FDA staff, call the appropriate number listed on the title page of
this guidance.
I. INTRODUCTION
This guidance is intended to help the public, Food and Drug Administration
(FDA) advisory committee members, and FDA staff to understand and implement
statutory requirements and FDA policy regarding public availability of information about
financial interests and waivers2 granted by FDA to permit individuals to participate in
advisory committee meetings subject to the Federal Advisory Committee Act (FACA) (5
U.S.C. App.). This guidance describes the basis and provides a format for public
disclosure of certain financial interests by special Government employees (SGEs) and
regular Government employees participating in these advisory committee meetings, and
provides a format for FDA waivers allowing participation in these meetings.3