March Madness: Upcoming US FDA Decision Dates To Watch

A dozen applications for new drugs and significant new indications are on the US FDA’s calendar of goal dates, including breakthrough-designated applications from Bristol-Myers Squibb and Boehringer Ingelheim.  

Shooting  basketball
The annual US college basketball tournament is not the only thing heating up this month. • Source: Shutterstock

New indications and formulations will make March a busy month for the US Food and Drug Administration, the Pink Sheet’s FDA Performance Tracker shows.

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US FDA’s Median Review Time Remains Less Than One Year Despite Swell Of Missed Goal Dates

 

Novel agents from the biologics center had a median review time of 10.6 months, beating the drugs center's median of 11.8 months thanks to fewer multicycle and more priority reviews.

ANDA Yo-Yo: FDA Receives Second-Lowest Submission Count In October After September Bolus

 

The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.

Metabolic And Endocrine Therapies Could Star Among US FDA’s Last 2024 Approvals

 

The December calendar features nearly 20 user fee goal dates, from Novo Nordisk’s Alhemo to Lexicon’s Zynquista.

New EU Fee Regulation: Smaller Firms & Orphan Drugs Will Still Benefit From Full Reductions

 

While annual fees for marketing authorization applications and annual payments to the European Medicines Agency are set to increase from 2025, micro-sized companies and SMEs that make orphan drugs will still benefit from full reductions.

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Pugilistic Vanda Collects Another NOOH As US FDA Defends Tradipitant Turndown

 

Vanda’s fight against a complete response letter for its gastroparesis drug results in a notice of opportunity for hearing on a formal FDA proposal to refuse to approve the NDA.

Tissue Biopsies: US FDA Urges Careful Balance Of Risk v Need In Clinical Trials

 

In new draft guidance, the US FDA recommends sponsors carefully weigh the circumstances for requiring tissue biopsies for clinical trial subjects and emphasizes the need to limit them in pediatric studies.

Trump’s US FDA Reforms Need Center Director, Staff Support To Succeed, Former Leaders Say

 
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Former FDA commissioners Mark McClellan and Scott Gottlieb, former acting commissioner Janet Woodcock and current commissioner Robert Califf offered advice on successfully implementing reforms and preventing a mass exodus of FDA employees as inklings emerge that the Trump team is already engaged on this front.