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Califf And Advisory Committees: Will He Push For Reforms?

 
• By Derrick Gingery

Confirmation hearing comment suggests FDA Commissioner nominee Robert Califf thinks an overwhelming advisory committee vote should give agency officials pause.

Robert Califf at 2021 Senate confirmation hearing
Robert Califf could influence advisory committee reforms if he becomes FDA commissioner. • Source: Screenshot

Robert Califf may be willing to give advisory committee opinions a little more influence should he become commissioner of the US Food and Drug Administration.

Califf hinted during his 14 December Senate confirmation hearing that an overwhelming advisory committee vote should warrant close scrutiny by...

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October US FDA User Fee Goals: Few Novel Agents, But Many New Indications As Shutdown Looms

 
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J&J’s Inlexzo Is A Rare 505(b)(2) NDA To Qualify For US FDA’s Real-Time Oncology Review

 
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A Johnson & Johnson executive tells the Pink Sheet in an interview how the company developed its pretzel-shaped intravesical drug releasing system for gemcitabine, which used design and materials to improve efficacy and ease bladder cancer treatment.

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Global Pharma Guidance Tracker – September 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.

October US FDA User Fee Goals: Few Novel Agents, But Many New Indications As Shutdown Looms

 
• By Bridget Silverman

October is unusually low on user fee goals for novel agents, but more than 20 applications for new indications and formulations will keep FDA staff busy, especially in oncology and ophthalmology.

EU CHMP Opinions And MAA Updates

 
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