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Podcast Special: Assessing US FDA Commissioner Robert Califf’s First 100 Days

 
• By Reed Miller, Elizabeth Orr, Ryan Nelson, Nielsen Hobbs, Hannah Daniel, Derrick Gingery, and Malcolm Spicer

Reporters and editors from the Medtech Insight and sister publications covering the pharmaceutical and health, beauty and wellness sectors look at Califf’s goals, accomplishments and trials during the early days of his second term.

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How will crises in the FDA's food program affect Califf's goals for the drug, biologics and device centers? • Source: Alamy

Reporters and editors from the Pink Sheet, MedTech Insight and HBW Insight discuss the first 100 days of US Food and Drug Administration Commissioner Robert Califf’s goals, accomplishments, trials and tribulations, across the drug, device and health and wellness sectors and whether ongoing and how crises like the infant formula shortage could affect them. They also consider the potential for lasting change at the agency going forward.

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More from Regulation

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

More from Policy & Regulation

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.