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A User Guide To FDA’s Expedited Programs For Serious Conditions

 
• By Sue Sutter

A handy side-by-side chart shows the criteria, advantages and timelines for the fast-track, breakthrough therapy and priority review designations and the accelerated approval pathway.

Please click here for a quick reference guide providing an overview of key elements of FDA’s four expedited drug development and review programs, including qualifying criteria, features and benefits, timelines and other considerations for sponsors.

The chart was adapted by “The Pink Sheet” from FDA’s May 2014 final guidance, “Expedited Programs for Serious...

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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.