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Isotretinoin REMS Modifications Show How Advisory Panel Can Push FDA To Change Its Mind

 
• By Sarah Karlin-Smith

US FDA makes five changes to ease burden of risk management program for acne drug – going further than the agency initially seemed comfortable with in March, though not always in line with what the generic sponsors were seeking.

close up of women with acne on her face
Changes to isotretinoin REMS should make access to the acne drug easier. • Source: Shutterstock

The US Food and Drug Administration agreed to five modifications to the isotretinoin Risk Evaluation and Mitigation Strategy including a relaxation of pregnancy test procedures following an advisory panel that stands out as an example of how a committee's input can shift the agency’s thinking.

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US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

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US FDA In ‘First Stages’ Of Reconsidering Black Box For Antipsychotics

 
• By Ramsey Baghdadi

Patient advocates and sponsors want the US to reconsider a 20-year-old class warning against the use of antipsychotics in patients with dementia. The agency is weighing the issue, but also defending the current labels of newer agents.

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• By Cathy Kelly

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New EU Approvals

 
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• By Bridget Silverman

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