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FDA Finalizes Comparative Safety, Efficacy Requirement For New Opioids

 
• By Kate Rawson

New opioids will need to provide a “significant advantage” over approved products under new requirements that treat opioids “differently” from other drug classes, outgoing Commissioner Gottlieb says.

Healthcare, opioid epidemic and drug abuse concept with the map of USA filled with oxycodone and hydrocodone pharmaceutical pills on the American flag

Throughout his two-year tenure at the US FDA, outgoing Commissioner Scott Gottlieb has been known for a deliberate, incremental approach to regulatory policy, ensuring both a consistent drumbeat of news while exhibiting constant (albeit often small) signs of progress.

That communications strategy was on full display at Gottlieb’s penultimate congressional appearance: a Senate Appropriations Subcommittee hearing on the...

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More from Product Reviews

More from Pink Sheet

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.