Will a New FDA User Fee Discourage Medical Device Innovation?

Bloomberg June 12, 2017: The NCHR is warning that a new FDA user fee could make the de novo pathway more appealing by speeding up device reviews, but at the cost of safety. NCHR says this fast-track process often skips clinical trials and lacks solid scientific proof, putting patients at risk.

Read More »

FDA Questions Effect of Abuse-Deterrent Opioids

June 13 2017: The NCHR cautions that opioids labeled as “abuse-deterrent” might not actually stop misuse and can still be abused, giving a false sense of safety. They urge the FDA to ensure that such labels accurately reflect the risks to protect patients from harm.

Read More »