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COVID-19 Vaccine EUA Process Compresses Advisory Committee Prep Too

 
• By Derrick Gingery

US FDA wants briefing documents when EUA is submitted to accommodate timely advisory committee reviews; unlike traditional assessment process, the agency does not appear interested in engaging in back-and-forth discussions with sponsors about portions of the briefing document that should be made public or redacted.

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Sponsors must include advisory committee presenter slides, as well as meeting briefing materials, with their coronavirus vaccine EUA request. • Source: Shutterstock

The US Food and Drug Administration expects coronavirus vaccine sponsors to begin preparing for an advisory committee meeting before their emergency use authorization request is even filed in order to comply with compressed assessment timelines.

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AMR-Targeting Drug Secures EMA PRIME Designation

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

US FDA’s March Approval Candidates Take Aim At Established Markets

 
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.

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‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

Global Pharma Guidance Tracker – February 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

EU CHMP Opinions And MAA Updates

 
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.