Laura Helbling

Latest From Laura Helbling
House ALS Bill Would Require US FDA ‘Action Plan’ – But Not Conditional Approval
US House of Representatives if moving forward with a bill to respond to advocacy from ALS patients for more attention from FDA. The bill focuses on planning and scientific support, not new pathways.
Providers Still See Drawbacks To Opioid Education Mandates
Participants in a US FDA meeting on opioid REMS did not treat a move to mandatory education as a foregone conclusion. Instead, they delved frequently into alternate approaches to enhance the education itself.
Mandatory Prescriber Education For Opioids; Is This The Time?
US FDA is once again asking whether its opioid Risk Evaluation & Mitigation Strategy program for opioids should make continuing education requirements mandatory for prescribers. This time there may be no choice but to move forward with the plan.
US FDA Works To Stay Ahead Of Benzodiazepine Misuse
FDA and NIH are looking to spark research on approaches to reduce use of benzodiazepines and to help mitigate issues with withdrawal associated with the widely prescribed therapies.
Ex-Commissioners See Mostly Positives In Public View Of US FDA After COVID
Three of the US FDA’s former leaders believe the agency is coming through COVID with its reputation intact. They still support making the agency independent of the broader Health & Human Services Department, but the urgency may be gone.
US FDA Exploring Options To Improve Study Of Drugs In Elderly
New incentives will most likely not be the immediate focus, but working group to explore ideas on enhancing understanding of drug effects in elderly populations will likely be formed by US FDA.