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US FDA Implementing Hybrid Work Policy In January

 
• By Derrick Gingery

Agency employees will have on-site, telework and remote possibilities, but options will depend on the center, office and job duties.

FDA hybrid work
Individual duties will help determine whether on-site, telework and remote working options will be available for FDA employees. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US Food and Drug Administration will not require all employees to resume their daily treks to the office going forward, choosing a “hybrid workplace model” that will go into effect in January 2023.

Commissioner Robert Califf made the change after the agency completed a six-month pilot exploring workplace flexibilities. The FDA said the...

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As US FDA Turns: Can Makary, Prasad And Pazdur Make It Work?

 
• By Michael McCaughan

The FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad, and Commissioner Martin Makary get along?

CBER Poised for Research Shakeup As Prasad Makes Unproven Claims About ‘Polluted Science’

 
• By Sarah Karlin-Smith

In an email to staff filled with unsupported accusations about the quality of the center’s research, CBER Director Vinay Prasad said no resources or time should be spent on ongoing projects started before he joined the FDA until discussed with him.

US FDA Cancer Office Keeps Hemorrhaging Staff, Most Land At Industry

 
• By Sarah Karlin-Smith

Merck, Lilly, and Johnson & Johnson are some of the pharma companies who have snagged the many staff leaving the FDA’s oncology positions. The Pink Sheet estimates CDER’s oncology division is operating with about a 20% vacancy rate.

CNPV II: Secondary Indications Feature In Second Batch Of US FDA Voucher Winners

 
• By Ramsey Baghdadi

Five of the six winners of the US FDA’s second batch of Commissioner’s National Priority Vouchers are for secondary indications. That is no accident, Commissioner Makary says.

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EMA’s Combined Scientific Advice Seeks To Boost Approvals For Drugs Tackling Public Health Threats

 
• By Francesca Bruce

A new service from the European Medicines Agency offers developers of products targeting public health emergencies combined regulatory advice on marketing authorization and clinical trials.

EU Medicines Network Taps Global Specialists To Tackle Capacity Crunch

 
• By Vibha Sharma

EU drug regulators are taking steps to strengthen their assessment capacity by widening access to specialists from outside the EU/EEA.

CNPV II: Secondary Indications Feature In Second Batch Of US FDA Voucher Winners

 
• By Ramsey Baghdadi

Five of the six winners of the US FDA’s second batch of Commissioner’s National Priority Vouchers are for secondary indications. That is no accident, Commissioner Makary says.