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US FDA Reorg: Defining The “Central” Purpose Of A Commissioner

 
• By Michael McCaughan

Scott Gottlieb will formally implement a new structure for the Office of the Commissioner just days before he departs from the job. That may be odd timing, but the new structure is in many ways a perfect capstone for Gottlieb’s tenure.

Manometers-Cooling-System

The timing certainly is odd: US FDA Commissioner Scott Gottlieb is announcing the formal implementation of a new structure for his office will take effect March 31 – just days before he will be leaving the job April 5.

The major element of the commissioner-level restructuring is the unwinding of the “directorate” approach set up by Margaret Hamburg at the start of the decade. Gottlieb wanted all of the...

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Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

 
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Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

More from Agency Leadership

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.