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Label Change Proposal From GPhA, PhRMA Makes FDA Responsible For Timing

 
• By Derrick Gingery

“Expedited Agency Review” idea would require an FDA review of proposed safety-related labeling changes before they are made and end the CBE-0 system brand companies already use and generics could be required to adopt.

Generic and brand drug industry groups now agree that the burden for requiring a safety-related labeling change should rest entirely with FDA, even if the process is initiated by sponsors.

In a rare collaboration, the Generic Pharmaceutical Association and Pharmaceutical Research and Manufacturers of America created an alternative

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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.