1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

Innovation In OTC Switches Takes Multimedia Approach In US FDA Draft Guidance

 
• By Malcolm Spicer

Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been switched from Rx to OTC. Draft guidance on innovative switch applications to be followed by rule-making in near future.

Woman using touch screen mobile phone with blur shopping mall

FDA's new approach for making more Rx drugs available over-the-counter, particularly for chronic conditions, allows sponsors to tap into digital media and other tools to help demonstrate that consumers can assess whether an OTC drug is appropriate for them and they can use the product safely.

Sponsors proposing Rx-to-OTC switches must show that a consumer can select a product and use it safely without a physician's intervention. Existing regulations require that a consumer must be able to make this evaluation using only information in an OTC product's Drug Facts label (DFL)

More from US FDA

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

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

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.

More from Agency Leadership