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Breakthrough, Fast-Track Pathways Match Their Hype Of Reduced Development Times - JAMA

 
• By Michael Cipriano

Although study was meant to be critical of expedited pathways, it showed that drugs with at least one of the designations experience lower clinical development times.

Female athletes running towards finish line on track field

The US FDA's breakthrough therapy and fast-track expedited pathways appear to be living up to their hype. A research letter published in the Journal of the American Medical Association (JAMA) found that development times for drugs that land either of the designations are shorter than those for drugs that do not receive them.

According to the study, authored by Harvard Medical School associate professor Aaron Kesselheim, new drugs and biologics approved between 2012...

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US FDA Commissioner Makary Is Learning To Appreciate His Staff

 
• By Michael McCaughan

After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?

‘Unprecedented Story’: Revoked EU Marketing Authorization Fails To Thwart Translarna Sales

 
• By Francesca Bruce

PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

US FDA Asking Questions About Commissioner’s Voucher Program With Details Scarce

 
• By Derrick Gingery

FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.

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EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.

US FDA Commissioner Makary Is Learning To Appreciate His Staff

 
• By Michael McCaughan

After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.