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Pink Sheet Podcast: Understanding The Impact Of The Latest HHS Layoffs On The US FDA

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

Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.

Pink Sheet podcast
Where could the layoffs hurt the FDA the most? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and Senior Editor Sue Sutter discuss the impact of the 3,500 layoffs on the US Food and Drug Administration, including the areas where the agency could lose some autonomy (:28). They also consider worries that the agency’s preparations for user fee reauthorization negotiations may be slowing because of the upcoming staffing cuts (24:09).

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This and other podcasts are available on the Pink Sheet podcast page, as well as the Citeline channel on Apple Podcasts, SoundCloud, TuneIn and Spotify Podcasts, and via smart speakers if one of these platforms has been set up as your default podcast provider.

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Pink Sheet Podcast: Understanding The Impact Of The Latest HHS Layoffs On The US FDA

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

Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.

Pink Sheet Podcast: US FDA Productivity Complaints Emerge, Internal Return To Office Headaches

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss industry worries about delays in the FDA’s work since the Trump Administration took office, as well as the chaotic return of staff to a White Oak headquarters that cannot handle them.

Pink Sheet Podcast: Buyouts, Departures and Other US FDA Chaos

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the early retirement and buyout offers to FDA employees and significant agency departures in the Center for Biologics Evaluation and Research and chief counsel’s office as a new commissioner moved closer to confirmation.

Pink Sheet Podcast: What We Learned From US FDA Commissioner Nominee Makary’s Confirmation Hearing

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

Pink Sheet reporters and editors discuss FDA Commissioner nominee Martin Makary answers to senators’ questions and the potential impact of his views on the agency.

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England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 
• By Eliza Slawther

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.

Brazil Catches Up With International Standards on Viral Safety Evaluations For Biotech Products

 
• By Francesca Bruce

The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.

Korea To Revise ‘Innovative Company’ Criteria Amid Calls From Foreign Industry

 
• By Jung Won Shin

South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.