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Trump On Right-to-Try: Gottlieb's 'Heading It Up'?

 
• By Derrick Gingery

Curious comment by president could place US FDA Commissioner in tough spot balancing his boss' priorities with his and staff's concerns about pending right-to-try legislation.

President Trump has put FDA Commissioner Scott Gottlieb at the front of his push to pass right-to-try legislation, whether Gottlieb wanted to be there or not.

During a Feb. 1 speech to a retreat for Republican lawmakers, Trump continued his push for legislation that would expand...

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More from Approval Standards

Best Laid Plans: A Chronology Of Post-Pandemic COVID-19 Vaccines

 
• By Bridget Silverman

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.

Novaxovid And mNexspike Reviewers

 
• By Bridget Silverman

Pink Sheet Drug Review Profile feature listing FDA staff who conducted the reviews of Novavax and Moderna's post-pandemic COVID-19 vaccines

Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By Kate Rawson

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

EMA Revives Face-To-Face Oral Explanations In Response To Industry Feedback

 
• By Vibha Sharma

The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.

More from Pathways & Standards

Cancer Drug Combos: US FDA Guidance Offers Options Beyond Factorial Trials

 
• By Manas Mishra

Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By Kate Rawson

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.