Laura Helbling
Latest From Laura Helbling
US Medicare Agency Reconsidering Proposed Accelerated Approval Payment Demo
The US Medicare agency is not moving forward with a proposal to cut payments for drugs with accelerated approval status pending further discussions with the FDA about whether new regulatory authorities have addressed concerns about timely completion of confirmatory trials.
US FDA Drug Center Tries New Approach To Old Consistency Problems
Drug developers should not expect the US FDA's new Quantitative Medicine Center of Excellence to dramatically impact the agency's long-standing problem of ensuring more consistent use of innovative regulatory approaches in application reviews.
Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan
US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.
Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan
US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.
A Final Push For US Hepatitis C Eradication Plan In 2024
The Biden Administration is hoping that it can attach funding for a national hepatitis C ‘subscription’ program into the delayed fiscal 2024 appropriations bills.
Menopausal Status Is Another Focus For US FDA Trial Inclusion Efforts
US FDA is emphasizing the need to assess the effects of menopause on drug safety and efficacy as a continuation of the agency’s efforts to encourage clinical trial sponsors to look more systematically for differences in clinical trial subpopulations.