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Pink Sheet Podcast: Clinical Trial Diversity, Off-Label Standard Of Care Issues, In-Person US FDA Adcomms

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams’ views on how the FDA can better ensure clinical trial diversity, questions about approving a new drug that would be used with a standard of care regimen that is off-label, and the agency beginning to schedule fully in-person advisory committee meetings.

Pink Sheet podcast
Will advisory committee meetings change upon their return to fully in-person sessions? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss former US Surgeon General Jerome Adams’ view that additional regulation is necessary to ensure industry complies with clinical trial diversity requirements (:27), as well as questions about the US Food and Drug Administration potentially approving Zevra Denmark A/S’ arimoclomol in Niemann-Pick disease type C, but with an unapproved standard-of-care regimen (15:00). They also consider any adjustments sponsors and others may encounter when the FDA returns to fully in-person advisory committee meetings in September (24:03).

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More from Diversity & Inclusion

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 
• By Anabel Costa-Ferreira

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

More from Clinical Trials

EMA Tackles Guidance Void As Proposals For External Controls Grow

 
• By Neena Brizmohun

The European Medicines Agency is working on defining when and how external controls can be accepted in clinical research. Among other things, it is looking at the planning, design, conduct, analysis and reporting of studies for which external controls are used.

New CTIS Feature To Bridge ‘Communication Gap’ Between Trial Sponsors & EU Assessors

 
• By Vibha Sharma

A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 
• By Eliza Slawther

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.