Sarah Karlin-Smith

2 weeks ago | insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith |Derrick Gingery

US FDA Could Miss User Fee Spending Triggers With House FY 2026 FundingFDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work. The House FY 2026 FDA appropriations bill could force non-user fee program cuts to ensure minimum spending levels are met, agency sources told the Pink Sheet. (Shutterstock)

3 weeks ago | insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |Sarah Karlin-Smith |Sue Sutter |M. Nielsen Hobbs

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget CutsPink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts. Could the FDA budget request offer clues on the agency's strategy for user fee reauthorization negotiations? • Source: Citeline/Shutterstock

3 weeks ago | feeds.feedblitz.com | Sarah Karlin-Smith

Key TakeawaysPanel members urged the FDA to permit local IRB oversight of bespoke gene therapies, arguing current regulation is forcing clinical trials to move overseas. Cell and gene therapy leaders want the US Food and Drug Administration to loosen its regulatory oversight of early clinical...

3 weeks ago | insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun. HHS Secretary Robert F. Kennedy Jr., CMS Administrator Mehmet Oz and NIH Director Jay Bhattacharya spoke at the FDA's 5 June cell and gene therapy panel. (Derrick Gingery)

3 weeks ago | insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER DirectorsThe remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions, a different approach than FDA Commissioner Martin Makary has suggested Prasad wants. New CBER Director Vinay Prasad said his role in product reviews will remain within the norms upheld by previous center directors. (Shutterstock)