FDA is invoking its new post-marketing study authorities to ensure that Pfizer Inc. submits all clinical study data on the withdrawn inhaled insulin brand Exubera.
By Michael McCaughan
Exubera Gone, But Not Forgotten: FDA Imposes REMS, Mandates Trials
Pfizer is no longer marketing inhaled insulin, but the regulatory work continues. FDA makes clear that any future inhaled insulin products will need a risk management plan and mandatory post-marketing studies.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.
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The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.
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The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.