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US FDA’s No Recording Meetings Rule Already Appears Flexible

 
• By Derrick Gingery

At least one sponsor has been recording meetings for several years, suggesting others could receive permission, but the decision comes with risks as well as benefits. As the agency again expands options for in-person meetings, sponsors may want to reflect on what works best for them.

Dictaphone
Before asking the FDA to record a formal meeting, sponsors should consider the potential benefits and risks of the move, attorney Jim Czaban said. • Source: Shutterstock

The US Food and Drug Administration’s rule against recording formal meetings may not be as hard and fast as suggested, although sponsors do not seem excited to exercise the option if it was available.

At least one sponsor already has been given permission to record an FDA meeting

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

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 Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

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Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.