Latest From Brenda Sandburg
Patient-Focused Drug Development Grants May Be Program’s ‘Most Significant’ Accomplishment Since 2019
US FDA has issued five grants for development of standard core clinical outcome assessments and related endpoints that can be used across disease areas and may produce more reliable data for regulatory decision-making.
Former chief medical officer’s conviction for misbranding Suboxone does not warrant mandatory exclusion from healthcare programs, complaint argues. It says individuals in similar situations, specifically former Purdue execs, were subject to permissive exclusion.
The director of the agency’s patient-focused drug development program talks to the Pink Sheet about how the program has improved the development and evaluation of new drugs, initiatives underway, and plans to standardize and harmonize the process.
US FDA’s Theresa Mullin envisions having a national catalog of standard core clinical outcomes assessment measures that could apply to every disease area.
Jazz’s REMS patent on distribution of Xyrem does not belong in the Orange Book because it is directed to systems rather than a method of using the drug, court rules, agreeing with FTC’s analysis.
Research institutions, CROs, biopharma industry and other stakeholders are asked to comment on potential governance structure that would determine when trials are needed to address disease outbreaks and other public health emergencies.