March 31, 2014. We have concerns about Sivextro for the treatment of adult patients with acute bacterial skin and skin structure infections. The main goal in antibiotic drug development is finding new drugs to target strains that are resistant to currently available drugs.
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NCHR Comments to FDA Advisory Committee on Anti-Infective Drug Dalvance
March 31, 2014. A careful analysis of the data calls into question the efficacy of Dalvance (Dalbavandin)… statistics indicate Dalbavandin patients are approximately twice as likely to have worse clinical outcomes compared to patients taking the comparison drug, vancomycin.
Read More »NCHR Testimony to FDA Advisory Committee on REASANZ (Serelaxin) Injection
March 27, 2014. Given the lack of credible evidence that this injected drug is more effective than placebo, we urge you to advise the FDA to NOT approve it at this time, and to require better research as well as subgroup analyses on African Americans and Latinos.
Read More »NCHR Testimony to FDA Advisory Committee on Visian Toric Implantable Collamer Lens
March 14, 2014. Myopia and astigmatism are extremely common and we approached today’s meeting with hope that the evidence would be solid so that people could benefit from this device. I’m sure you did too. However, we have 2 substantial concerns.
Read More »Conference – Evidence for New Medical Products: Implications for Patients and Health Policy
June 13, 2014. Better implementation of evidence-based medicine can improve the quality and cost-effectiveness of health care in the U.S. This can be challenging in evaluating newly approved drugs and medical devices.
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