July 30, 2019. To ensure that requiring the availability of blister packaging does not have unintended consequences that outweigh any benefits, we encourage the FDA to study blister packaging for outpatient IR-opioid dispensing to assess how such packaging influences prescribing and usage, and thus affects the misuse or abuse of opioids.
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NCHR Testimony at FDA’s Limited Population Pathway for Antimicrobials & Antifungals Meeting
July 12, 2019. There is broad agreement that there is a need to develop new antimicrobials to treat serious or life-threatening infections, however we have serious concerns about FDA’s draft guidance describing the Limited Population Pathway (LPAD).
Read More »NCHR Comments on USPSTF Draft Recommendations on Abdominal Aortic Aneurysm Screening
July 12, 2019. We support the USPSTF draft recommendation related to screening for AAA in asymptomatic adults 50 years and older. The differences in prevalence, risks of surgery, likelihood of benefit, and amount of available evidence support the need for different recommendations based on gender/biological sex and smoking history.
Read More »NCHR Testimony on Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents
June 20, 2019. We agree with the FDA and the Panel that the increased risk for death for patients treated with paclitaxel-coated balloons or –eluting stents, as shown in the meta-analysis of randomized pivotal trials, is very concerning. Any potential increase risk for death is important for health care professionals and patients to know about, so that they can make appropriate decisions about whether to use a product.
Read More »NCHR Testimony on Pretomanid for Tuberculosis
June 7, 2019. While new treatments are needed, it is impossible to accurately determine the risks or benefits of a new TB treatment without a randomized trial or a matched control group within the same trial. As clinicians and patients, you deserve to know the benefits and risks before deciding which treatments to use. This information is needed before approval, not years later.
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