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US FDA May Make Pre-Recorded Virtual Adcom Presentations Available Before Meeting

 
• By Derrick Gingery

The move is intended to streamline virtual advisory committee meetings, FDA official says.

Digital Network Connections, Technology Background - Cloud Computing Design Concept with Laptop Computer and World Map
Virtual advisory committee meetings need sponsor and meeting chair buy-in to move forward, FDA official says. • Source: Shutterstock

Sponsor presentations could have a lot more time to sink in during a virtual US Food and Drug Administration advisory committee meeting than at the in-person variety.

Among the ideas that could be piloted is not only pre-recording sponsor presentations and other sessions, but also releasing the...

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89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
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US FDA Emphasizes Primary Endpoint Primacy In Vatiquinone, Lytenava CRLs

 
• By Bridget Silverman

The complete response letters call for a new trial for PTC’s vatiquinone and more confirmatory evidence for Outlook Therapeutics’ Lytenava, while Telix’s Zircaix CRL shows quality challenges for a novel radiopharmaceutical approach.

More from Regulatory Trackers

US FDA Emphasizes Primary Endpoint Primacy In Vatiquinone, Lytenava CRLs

 
• By Bridget Silverman

The complete response letters call for a new trial for PTC’s vatiquinone and more confirmatory evidence for Outlook Therapeutics’ Lytenava, while Telix’s Zircaix CRL shows quality challenges for a novel radiopharmaceutical approach.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Global Pharma Guidance Tracker - July 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

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.