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Laura Helbling

Laura Helbling is Director of Research at Prevision Policy and a Senior Writer at The RPM Report (now Pink Sheet). Laura has a degree in magazine journalism from the University of Missouri School of Journalism.

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.

Neurology Politics

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.

Post Market Regulation & Studies Safety

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.

Post Market Regulation & Studies Safety

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.

Drug Safety Post Market Regulation & Studies

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.

FDA Politics

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.

Research & Development Drug Approval Standards
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