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Biosimilar User Fee Collections Rise, But Little Spent On Program Costs

 
• By Sue Sutter

FDA attributes large carryover balance to uncertainty in knowing when it has reached statutory funding threshold that triggers access to fees.

FDA spent more overall on the Biosimilar User Fee Act program in fiscal year 2015 but relied less on user fees.

In 2015, the agency had net fee collections of $22.8m under BsUFA but spent only $2.3m in fees to support...

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More from United States

Pink Sheet Podcast: US FDA Changes COVID-19 Vaccine Labeling, Reimbursement Confusion Rises

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

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

US FDA’s ARIA Analysis Adds Earlier Scan To Biogen/Eisai Leqembi Label

 
• By Bridget Silverman

Six deaths early in treatment inspired a new safety requirement for Biogen/Eisai’s Leqembi to promote early identification of patients affected by the well-known risk of amyloid-related imaging abnormalities with edema (ARIA-E).

COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad

 
• By Sue Sutter

The CBER director rejected Pfizer’s assertions that pediatric dosing gaps, supply constraints and comparative mRNA content justify keeping the vaccine under emergency use authorization for younger children.

New US FDA AI Councils Will Focus On Internal, External Policy

 
• By Sarah Karlin-Smith

The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.

More from North America

New US FDA AI Councils Will Focus On Internal, External Policy

 
• By Sarah Karlin-Smith

The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.

US FDA Updates COVID-19 Vaccine Formulations, Revokes EUAs, ACIP Use Decision Next

 
• By Sue Sutter

All COVID-19 vaccines are labeled for individuals 65 years and older or those with risk factors, and Moderna’s Spikevax is the only vaccine indicated for children as young as six months now that Pfizer’s emergency use authorization has been rescinded.

Colorado Board Adopts Medicare Maximum Fair Price For Enbrel, Assumes Amgen ‘Amenable’

 
• By Cathy Kelly

The state’s prescription drug affordability board could be the first to recommend an upper payment limit for a prescription drug.