1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

Trump Order Reducing Regulation Might Imperil FDA Good Guidance Practices

 
• By Derrick Gingery

Executive order mandating two existing regulations be eliminated for every new one issued includes guidances, raising questions about how FDA will communicate with industry going forward.

FDA entrance sign 2016

President Trump's executive order intended to reduce industry's regulatory burden could wind up forcing FDA to curtail its guidance practices, creating more uncertainty.

The order, signed Jan. 30, requires that federal agencies identify at least two existing regulations that can be eliminated for...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA

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.

More from Agency Leadership

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.