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Duragesic, Generics May Warrant Risk Management Plans, FDA Says
The agency will continue to monitor incidents of abuse or misuse of fentanyl transdermal systems and "may consider" requesting brand and generic manufacturers to implement a voluntary risk management plan, FDA says in denying citizen petition requests to delay approval of Duragesic generics.
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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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Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US, including potentially introducing new intermediaries into the system. Questions on MFN's feasibility and why it may be “catastrophic” to biopharma were also part of the discussion
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Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.
Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions
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The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.