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Patient Experience Data: US FDA’s Evidentiary Standards Should Reflect Intended Use

 
• By Sue Sutter

Degree of rigor may vary depending upon intended use of the data throughout a drug’s lifecycle, stakeholders say in comments on FDA’s first patient-focused drug development draft guidance; industry and advocates push for clarity on interactions to discuss patient experience studies with FDA staff and the promotional implications of such data.

The US FDA should clarify the level of rigor needed for collecting patient experience data based upon how that information will be used in a drug’s development, industry and advocacy groups tell the agency.

In comments on a June draft guidance on collecting comprehensive and representative input, stakeholders pressed FDA to better define the different types of regulatory decisions that could be supported by patient experience

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Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
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US FDA Advisory Committee Misperceptions Abound … At HHS

 
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HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
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Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
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Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
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Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
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Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
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