Advisory Committee Laws, Regulations and Guidance

FDA's advisory committee program is governed by a number of Federal laws and regulations that set forth standards for convening advisory committees and reviewing potential conflicts of interest, among other things.  FDA also has developed guidance documents that describe FDA's recommendations and policy related to our advisory committees.

We make these laws, regulations, and guidance documents available through our web site to provide ready access to the statutory and regulatory framework that FDA advisory committees operate within and to describe the steps that FDA has taken to enhance decision making, increase transparency, and strengthen public confidence in our advisory committee program.

Laws

• Federal Advisory Committee Act (5 U.S.C. app)
• Government in the Sunshine Act (5 U.S.C. 552b)
• Acts Affecting a Personal Financial Interest (18 U.S.C. 208)

Regulations

• Federal Advisory Committee Management Final Rule (41 CFR 101-6 and 102-3)
• Public Hearing Before a Public Advisory Committee (21 CFR 14)
• Interpretation, Exemptions,and Waiver Guidance Concerning 18 U.S.C. 208 (5 CFR 2640)
• Impartiality in Performing Official Duties (5 CFR 2635.502)

Guidances

• Advisory Committee Guidance Documents

For More Information - Contact:

Advisory Committee Oversight and Management Staff
Office of the Commissioner

(800) 741-8138

(301) 443-0572

Food and Drug Administration

Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave
Silver Spring, MD 20993
United States