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US FDA’s Post-Aduhelm Reforms Include Updated Alzheimer’s Development Guidance, Record-Keeping On Sponsor Meetings

 
• By Nielsen Hobbs

Agency already had an action plan in hand to address concerns with the aducanumab review even before the controversial approval, but it has not been fully implemented yet. A House committee report is another nudge.

Alzheimer's seas perspectives
FDA will continue to have to navigate the treacherous seas of the Aduhelm controversy in 2023. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US Food and Drug Administration has several policy updates planned to address elements of the controversial review of Biogen, Inc./Eisai Co., Ltd.’s Aduhelm, but the timeline for the agency to finally implement them remains unclear.

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Political Official Pushing Novavax To Conduct COVID-19 Vaccine Postmarket RCT

 
• By Sarah Karlin-Smith

In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.

Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

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

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

Political Influence And The US FDA: A New Era?

 
• By Michael McCaughan

FDA Commissioner Martin Makary declared during an interview with former Fox News host Megyn Kelly that there “should be nothing political” about the US FDA, but it feels like politics is infecting the agency in unprecedented ways about three weeks into his tenure.

US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
• By Sue Sutter and Derrick Gingery

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.

More from Pink Sheet

Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

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

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

Vertex’s Alyftrek For CF Among Six Orphans On Track For Pan-EU Approval

 
• By Eliza Slawther

The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.

Quotable: Top Experts On Policy Hot Topics

 
• By Anabel Costa-Ferreira

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.