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Once More, With Statistics: FDA Defends Division Productivity Differences

 
• By Bridget Silverman

Is it a problem that new drugs clear some review divisions faster than others? FDA analysis attributes differences to the proportion of applications qualifying for expedited review – a natural outgrowth of the priority placed on medical advances – not a management problem in need of a fix.

FDA added statistical ballast to its argument that differences in review times between its divisions stem from differing levels of innovation and scientific understanding across diseases with a new analysis of 10 years of novel drug approvals by the Center for Drug Evaluation and Research.

The upcoming reauthorization of the Prescription Drug User Fee Act is pushing FDA to make its case clearly and formally....

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More from Approvals

Cancer Patient-Reported Outcomes Find Fertile Ground In GVHD, Myelofibrosis Labeling

 
• By Bridget Silverman

The FDA reviewed its efforts to bring PROs into cancer drug development at its 10th annual workshop on clinical outcome assessment in cancer trials.

New EU Filings

 
• By Neena Brizmohun

Kashiv BioSciences/Alvotech/Advanz Pharma’s biosimilar version of omalizumab is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

EU Decision Time For Insmed’s Brensocatib And Sanofi’s Belumosudil

 
• By Eliza Slawther

Insmed’s first-in-class bronchiectasis drug, brensocatib, is among the products that are up for an opinion by the European Medicines Agency’s human medicines committee this week on whether they should be approved for use in the EU.

Why EU Accelerated Assessments Are Harder To Secure Than US Priority Reviews

 
• By Neena Brizmohun

This second of a two-part series of articles on accelerated assessments and priority reviews explores why the EU mechanism remains underused compared to its US counterpart, how it might be improved, and how sponsors can improve their chances of securing an expedited drug review in Europe.

More from Product Reviews

New EU Filings

 
• By Neena Brizmohun

Kashiv BioSciences/Alvotech/Advanz Pharma’s biosimilar version of omalizumab is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Relacorilant, Navepegritide And Icotrokinra Among Latest EU Filings

 
• By Neena Brizmohun

Corcept’s relacorilant, Ascendis’s navepegritide and J&J’s icotrokinra are all investigational products that are now under review for potential marketing authorization in the EU as well as in the US.

EU Decision Time For Insmed’s Brensocatib And Sanofi’s Belumosudil

 
• By Eliza Slawther

Insmed’s first-in-class bronchiectasis drug, brensocatib, is among the products that are up for an opinion by the European Medicines Agency’s human medicines committee this week on whether they should be approved for use in the EU.