Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.
The process for eliminating a Risk Evaluation and Mitigation Strategy could become more transparent thanks to the prescription drug user fee reauthorization.
Among the final details the PDUFA VII Postmarket subgroup negotiators considered industry interest in commitment letter language describing “a process...
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The FDA said new molecular entity application reviews increased and cost less in fiscal year 2024, a potentially encouraging sign for industry.
The administration's first actions on drug advertising linked to a new MAHA Strategy report may suggest more specifics about its plans exist than in the limited text of the report.
US FDA's regulatory flexibility for rare diseases is newly enshrined in the FDA's "Rare Disease Evidence Principles," but upcoming goal dates include some real-world examples of challenging orphan applications.
The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.
The Give Kids A Chance Act would renew the PRV program that began to sunset in December 2024. The House Energy and Commerce Committee advanced the pediatric- and rare disease-focused package, but also included generic drug transparency provisions.
Recently released CRLs for unapproved products contain recommendations for new studies, including design element details and advice to consider different submission pathways.
Sponsors should systematically incorporate real-world evidence generation in all development programs, advises an epidemiology-forward “blueprint” Aetion executives developed.
