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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

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

Not So Fast: Trump Team Paints US FDA Review Times As Too Slow

New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.

Drug Review FDA

US FDA ‘Bruised’ But Not Broken: Former Commissioners See Agency Intact Amid Transition

Three former commissioners believe FDA has come through the Trump administration relatively unscathed when compared to the reputational damage suffered by other government agencies. Will the Biden team agree?

FDA Leadership

‘Bruised’ But Not Broken: Ex-Commissioners See FDA Intact Amid Transition

Three former commissioners believe FDA has come through the Trump Administration relatively unscathed when compared to the reputational damage suffered by other government agencies. Will the Biden team agree?

FDA Elections

Rx Vial Size: FDA Stresses Safety Issues Amid Push To Find Savings For Payors

There may be significant savings from eliminating wasteful packaging for high cost specialty drugs. The US FDA, however, is urging policy makers not to overlook the importance of patient safety in packaging issues.

Drug Safety Government Payers

New Tech Payment For Old Antibiotics: US Medicare Effort Brings Lots Of Interest

CMS streamlined process for enhanced payments is having an impact: seven antibiotic applications for New Technology Add-On Payment status in 2021—including one for a product that has been marketed for more than five years.

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