Although patients may benefit from olanzapine/samidorphan by experiencing lower weight gain, the risks are too high to justify approval.
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NCHR’s Testimony at FDA Advisory Committee Meeting on “Abuse-Deterrent” Amphetamine Sulfate Immediate-Release Oral Capsules
The drug should be labeled with an accurate description of its properties, not “abuse deterrent,” so that patients, family members, and healthcare providers do not erroneously assume the drug is less addictive.
Read More »NCHR Public Comments on the AHRQ Draft Systematic Review of Cervical Ripening in the Outpatient Setting
We support the review’s examination of the relative risks and outcomes of cervical ripening in the outpatient compared to the inpatient setting. However, an overarching problem in the review is that it does not examine the role of patient-centered outcomes and satisfaction.
Read More »NCHR’s Testimony to FDA Regarding Reclassification of 4 Medical Devices
September 8, 2020. Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Meg Seymour, a senior fellow at the center. Our center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding […]
Read More »NCHR’s Public Comments on the FDA’s Draft Guidance Regarding the Development of Anti-Infective Drug Products for the Pediatric Population
We have several recommendations regarding the FDA’s draft guidance regarding the development of anti-infective drugs for the pediatric population.
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