March 18, 2019. We support FDA’s efforts to update their approach to address growing concerns about cybersecurity risks in medical devices through the premarket submission process. Software and medical devices have become increasingly interconnected and vulnerable to network-related cybersecurity breaches, which puts patients at risk. We have several concerns and recommendations to improve the updated guidance.
Read More »On Health Policy
NCHR Statement to the Maryland State House Environmental Committee, Artificial Turf
March 1, 2019. NCHR’s Jack Mitchell made a statement at the Maryland State House Environmental Committee regarding artificial turf and its negative effects.
Read More »Advancing Tobacco Control Practices To Prevent Initiation of Tobacco Use Among Youth and Young Adults, Eliminate Exposure to Secondhand Smoke, and Identify and Eliminate Tobacco- Related Disparities: Request for Information.
February 11, 2019 Tobacco use among youth and young adults is a large health concern. NCHR wrote a comment to the CDC regarding efforts to minimize usage among this population.
Read More »The USPSTF Draft Recommendations on Medication Use to Prevent Breast Cancer: Comments by Women’s Health Experts
February 11, 2019. NCHR writes on behalf of five nonprofit health organizations that have examined issues pertaining to primary prevention of breast cancer for decades and urge the USPSTF to consider revising their current recommendations on breast cancer risk reducing drugs.
Read More »NCHR comments on FDA’s Framework for Real-World Evidence Program
February 5, 2019. FDA needs to maintain high standards for evidence of effectiveness and safety whether the source of the data is from traditional clinical trials or RWE. Double-blind, randomized clinical trials remain the gold standard, and along with other types of well-controlled trials (including those that generate RWE), provide information that observational studies cannot. RWE should supplement rather than replace traditional, randomized and blinded controlled clinical trials except in situations where such traditional clinical trials are not possible.
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