US FDA
Richard Pazdur plans to remain involved in drug development after leaving the FDA.
As the FDA sees another quarter with a net loss of employees in CDER and CBER, Pink Sheet editors discuss the potential impact and where it could manifest.
CDER and CBER added more people in the first quarter of FY 2026 than the previous two quarters combined, but departures still outnumbered the additions.
Recommendations to mitigate attrition among clinical research and drug manufacturing investigators at the FDA have not been implemented, and a Strategic Workforce Plan aimed at addressing recruiting, retention and training challenges has been shelved, the Government Accountability Office said.
The FDA does not like the idea, in part because estimating annual revenue likely would be tougher.
‘Over the hump, and about to pick up speed’ is how Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, described the category as she sets out the agency’s plans for more biosimilar progress domestically and internationally in 2026.
The agency veteran brings extensive generic and new drug experience to Acting CDER Director Tracy Beth Høeg’s leadership team and fills a position that has been vacant since Douglas Throckmorton retired a year ago.
Pink Sheet editors discuss the average speed of FDA novel drug application reviews in 2025 and consider whether staffing departures and general upheaval throughout the year will impact times in 2026.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
Leadership changes and the departure of numerous experienced staff are “going to start to catch up” and will negatively impact application quality and drug approvals in the coming year, former Commissioner Scott Gottlieb predicted.
The FDA is exploring a new model that would let venture capital firms act as prime contractors, giving their startups direct access to federal contracts.
Pink Sheet interviews with ex-FDA leaders and agency experts offer guidance for drug developers navigating an agency playing by a different and ever-shifting rulebook.
Pink Sheet editors discuss Richard Pazdur’s concerns about the Commissioner’s National Priority Voucher program and the idea that the FDA could release action packages for unapproved products in addition to complete response letters.
The Swiss pharma co-authored a “call for bold life sciences investment” with the Eurasia Group, critiquing global trade policy and advocating “innovation-friendly” reforms, including moving away from reference pricing.
The FDA also is working to better explain the program internally, including holding a town hall for FDA staff in February, as questions about the pilot’s transparency, decision-making and resource strain increase.
Novavax's John Jacobs discussed the company's response to FDA pressure and Takeda's Andy Plump addressed regulatory uncertainty in the US during the J.P. Morgan Healthcare conference.
The new expedited program lacks transparency and clear operating procedures, while review timelines will further strain demoralized staff, former Oncology Center of Excellence Director Richard Pazdur said.
Pink Sheet editors and special guest Michael McCaughan discuss the legacy of long-time Oncology Center of Excellence Director Richard Pazdur, who retired from the FDA in December.
Commissioner Martin Makary told staff that more than 400 new people are being onboarded, although where they will be placed is unclear.
Richard Pazdur joined the US FDA almost a decade after the accelerated approval pathway was invented, but no one played a larger role in shaping its use in the 2020s.