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FDA Staying The Course Under Ostroff; Hamburg’s Concerns Will Remain Focus

 
• By Derrick Gingery

Acting FDA Commissioner says he can’t envision any new major priorities that would emerge in the short-term.

Stephen Ostroff does not appear willing to set his own agenda for FDA, at least for now.

The new acting commissioner has been on the job 14 days following Margaret Hamburg’s departure earlier this month

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More from North America

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.