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Key FDA Officials From Generics And Biosimilars User Fee Programs Laid Off, Said AAM

A Major Wave Of Layoffs Across Multiple FDA Departments Happened On 1 April

 
• By Urtė Fultinavičiūtė

Off-patent drug trade groups expressed their concerns that personnel and expertise cuts will affect the agency’s ability to review and approve generics and biosimilars.

Concept of layoffs. People walking in a line down a red path
(Shutterstock)

Mass staff layoff upheaval at the US Food and Drug Administration has also affected the off-patent drug offices on 1 April, warned trade group the Association for Accessible Medicines.

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More from Regulation

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By Dave Wallace

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

OGD’s Policy Office Cut To Have ‘Profound’ Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

 
• By Urtė Fultinavičiūtė

The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.

Cardinal Looks Ahead To A New Decade For US Biosimilars

 
• By Dave Wallace

In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.

More from Generics Bulletin

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

Who’s Hired? Botox Biosimilar Developer Aeon Takes CEO From Rival Revance

 
• By Dave Wallace

Aeon Biopharma has picked up Revance Therapeutics executive Rob Bancroft to serve as its new CEO as it continues to pursue a biosimilar version of Botox. Meanwhile, Coherus has lost its chief commercial officer, as Viatris, Sandoz and Medicines for Ireland have announced new appointments.

OGD’s Policy Office Cut To Have ‘Profound’ Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

 
• By Urtė Fultinavičiūtė

The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.