CHICAGO, March 26, 2026 /PRNewswire/ -- Sarfaraz K. Niazi, Ph.D., adjunct professor at the University of Illinois Chicago and a regulatory science expert, today announced the filing of a formal Citizen Petition with the U.S. Food and Drug Administration under 21 CFR §10.30, calling for immediate action to finalize long-delayed conflict-of-interest (COI) guidance for FDA advisory committees.

The petition follows findings by the U.S. Government Accountability Office that the FDA has not finalized required COI guidance more than 13 years after a statutory mandate under the Food and Drug Administration Safety and Innovation Act (FDASIA, 2012), and has not provided a timeline for completion.

"The integrity of FDA advisory committees depends on transparent and consistently applied conflict-of-interest standards," said Niazi. "The current absence of finalized guidance creates uncertainty around how financial conflicts are evaluated and managed, particularly in high-stakes regulatory decisions."

The petition notes that the FDA withdrew prior descriptions of its COI evaluation processes in 2019 without issuing updated guidance. Data cited in the filing indicate that from 2018 to 2024, advisory committees recorded more than 120 recusals and over 50 waivers granted to members with identified financial conflicts, underscoring the operational significance of COI determinations.

The filing requests that the FDA establish a definitive timeline for issuing COI guidance, publish interim evaluation criteria, implement a standardized and auditable framework, and consider independent oversight mechanisms. It further asserts that the prolonged delay may constitute "unreasonable delay" under the Administrative Procedure Act (5 U.S.C. §706).

The petition has been submitted through Regulations.gov, creating a formal administrative record and triggering the agency's obligation to respond. Copies have been shared with Congressional oversight and appropriations committees.

Niazi, who has published extensively on regulatory policy and biosimilars, stated that the petition is intended to reinforce the FDA's role as a global leader in regulatory science by strengthening transparency and governance.

About Sarfaraz K. Niazi

Sarfaraz K. Niazi, Ph.D., is an adjunct professor at the University of Illinois Chicago and an expert in biosimilars and regulatory science. His work focuses on improving efficiency, transparency, and scientific rigor in drug development and regulatory decision-making.

Media Contact:

Sarfaraz K. Niazi, Ph.D.

Email: niazi@niazi.com

Phone: +1-312-297-0000

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