FDA Archives

Testimony of Dr. Diana Zuckerman About IV Tramadol Before FDA Advisory Committee

February 15, 2022: NCHR testifies against the opioid, tramadol, administered by IV to the FDA Advisory Committee.

Public Comment PDUFA VII Commitment Letter (Docket #FDA-2021-N-0891) From the National Center for Health Research

October 28, 2021: NCHR comments on the proposed PDUFA VII Commitment Letter from the FDA.

Statement by Dr. Diana Zuckerman on Sintilimab at FDA Advisory Committee on Oncologic Drugs

February 10, 2022: NCHR president Dr. Diana Zuckerman testifies to the FDA Advisory Committee on Oncologic Drugs on Sintilimab.

NCHR Comments on FDA’s Draft Guidance for Industry on Using RND to Support Regulatory Decision-Making

January 24, 2022. Although well-designed RWD and RWE studies can provide useful information about drug safety and even effectiveness, there are major shortcomings if RWD and RWE studies replace rather than supplement data from well-designed clinical trials. We therefore strongly encourage the FDA to make it clear that studies based on RWE should only be considered to provide supplemental evidence that can support regulatory decision-making for drugs and biological products.

What’s Wrong with the FDA?

Washington Monthly, January 20, 2022: If Robert Califf, the White House nominee for commissioner of the FDA, is confirmed by the Senate, he’ll take the reins of an agency with its reputation in tatters. Once revered as the global leader in drug regulation, the FDA has approved one bad drug and medical device after another over the past 30 years, leaving staff demoralized and overseas regulators scratching their heads. NCHR and other experts provide recommendations for improvements.