How Many People Can Squeeze Into A Mid-Cycle Meeting? For Savaysa, The Number Is 70

NDA’s complexity and a major efficacy review issue on the a-fib indication help explain the large contingent of FDA and sponsor participants in meetings required under the PDUFA V review ‘Program.’

The complexity of Daiichi Sankyo Inc.’s NDA for the anticoagulant Savaysa (edoxaban) appears to have resulted in mid- and late-cycle meetings that involved an extraordinary number of participants from FDA and the sponsor.

A total of 70 people were involved in a 90-minute, mid-cycle teleconference June 24, including 40 staffers from FDA and...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

US FDA Pediatric Adcomm To Examine HPV, Flu, Dengue Vaccines: No News Is Good News?

 
• By 

Pediatric Advisory Committee will weigh the FDA's recommendation that routine safety monitoring continue for Merck & Co's Gardasil and Sanofi's Fluzone and Dengvaxia despite a political climate that has been unkind to vaccines.

Medicaid Changes Could Have Major Impact on Recent Coverage Improvements

 
• By 

Insurance trade groups warned that the Big Beautiful Bill destabilize Medicaid and result in the largest ever roll-back in health care coverage in the US.

Drug Sponsors Can Help Shape Agenda For FDA/EMA Pediatric ‘Cluster’ Calls

 
• By 

Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.

US Budget Bill Eases IRA Price Controls But Coverage Losses Will Impact Pharma

 
• By 

The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.

More from North America

US Budget Bill Eases IRA Price Controls But Coverage Losses Will Impact Pharma

 
• By 

The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By 

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.