April 7, 2025: NCHR responded to FDA’s request for public comments regarding its guidance on sex differences in studies used as the basis for FDA approval. We strongly support most of the FDA’s proposed guidance, but we note that the agency’s has never required adequate representation of both sexes and so has failed to ensure that all drugs and devices approved for males and females are proven to have benefits that outweigh the risks for both males and females. If products are not adequately tested on a meaningful number of females and males, they should not be approved for females and males.
Read More »Medical Care for Adults
The National Center for Health Research reviews important new research as soon as it is published. We cut through the hype regarding various medical treatments to let you know what is proven and what is unknown about the risks and benefits of various treatment options. We do not accept funding from the companies that make medical products, so you can trust that our information is based on science, and not biased by financial ties to the treatments we’re evaluating.
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Public Comment of National Center for Health Research Regarding Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway
March 10, 2025: National Center for Health Research supports FDA’s decision to require that a confirmatory trial is “underway” before granting accelerated approval, but the definition of underway needs to be defined stringently and clearly. In our written public comment, we recommended setting specific benchmarks and stronger oversight to ensure timely trial completion so that patients and physicians can make informed medical decisions about products approved under the accelerated program. We also state that the closer to completion the confirmatory trial is at the time of accelerated approval, the more useful the research evidence is likely to be. We also urge that no exceptions be made to the requirement.
Read More »As Trump Administration Probes Long-Approved Medications, Could FDA Revoke Approvals?
Medscape March 6, 2025: MAHA Commission will study psychiatric, ADHD, and weight loss drugs’ impact on children. NCHR’s Diana Zuckerman agrees we need better evidence that the benefits of these drugs outweigh the risks.
Read More »The FDA’s misguided thinking on antibiotics
STAT, February 10, 2025: Why are so many people dying from infections? In this op-ed, Diana Zuckerman and John Powers discuss that the main problem isn’t antimicrobial resistance; the problem is the way antibiotics are studied and approved. Research shows we can save lives with better studies and FDA approval standards that focus on patients and not bugs.
Read More »National Center for Health Research Public Comment on FDA Draft Guidance: Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics
February 4, 2025: In our written public comment, we urged FDA to improve its draft guidance on the accelerated approval process by requiring and enforcing timely confirmatory trials proving meaningful clinical benefit based on validated measures of overall survival and quality of life.
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