https://www.fda.gov/regulatory-information/search-fda-guidance-documents/public-availability-advisory-committee-members-financial-interest-information-and-waivers

https://archive.ph/kcMTx

1

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