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Watching The Review Clock: Are US FDA Goal Date Extensions Reason For Optimism?

 
• By Bridget Silverman

Novel agents that received three-month user fee goal date extensions have a slightly higher approval rate than novel applications overall.

Stopwatch (shutterstock_157284068)
• Source: Shutterstock

Biogen, Inc. and Eisai Co., Ltd.’s announcement of a three-month extension to the PDUFA goal date for the potential Alzheimer’s disease therapy aducanumab cast a spotlight on what is usually a fairly mundane regulatory event: a three-month extension to the goal date.

Analysts greeted the 29 January 2021 announcement of the new 7 June target with a degree of optimism, noting that...

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

Rese-Cel CAR T Therapy Secures EMA PRIME Designation

 
• By Neena Brizmohun

Cabaletta’s rese-cel is among the latest investigational drugs that have won a place on the European Medicines Agency priority medicines scheme. Meanwhile, 11 products were denied PRIME designations.

October US FDA User Fee Goals: Few Novel Agents, But Many New Indications As Shutdown Looms

 
• By Bridget Silverman

October is unusually low on user fee goals for novel agents, but more than 20 applications for new indications and formulations will keep FDA staff busy, especially in oncology and ophthalmology.

OMUFA Reauthorization: US FDA Would Identify Rx-OTC Switch Candidates, Work With Sponsors

 
• By Kate Rawson

The Senate “SMART OTC” Act would require the FDA to identify product categories that could be eligible for an Rx-to-OTC switch and create a framework to work with sponsors.

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‘Chubby Labels?’: Generic Entresto Approval Was Lawful, D.C. Appeals Court Finds

 
• By Dean Rudge

MSN Laboratories wins another case against Novartis and will keep approval for its generic version of Entresto. The decision effectively confirms that US FDA can approve ANDA labels that make limited wording changes to carve around patent-protected indications, reinforcing the agency’s flexibility.

EU Pharma Package: Keep Patients Front & Center In Defining Unmet Medical Need

 
• By Francesca Bruce

EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.

CDC Should Boost Vaccine Monitoring Transparency, Communication - National Academies Report

 
• By Sue Sutter

The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.