US FDA's Antimicrobial Head Ed Cox Leaves For Regeneron; Agency Needs New LPAD Champion

Long-time deputy John Farley becomes acting director of the Office of Antimicrobial Products. Cox, who served as the director of the office for more than a decade, joins Regeneron to serve as vice president of regulatory affairs.

FDAEntrance_1200x675

As the US Food and Drug Administration continues to finalize its guidance on the limited population antibacterial drug (LPAD) pathway, it will have to do so without its lead antimicrobial czar Ed Cox, who recently departed the agency for a position at Regeneron Pharmaceuticals Inc.

Cox, who served as director of the Office of Antimicrobial Products since 2007 and in other roles at the FDA starting in 1998, began work at Regeneron on 26 August as vice president of regulatory affairs

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

More from US FDA

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

More from Agency Leadership

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.