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CDER Director Woodcock Plans Changes To Drug Reviews During OND Transition

 
• By Kate Rawson

In podcast interview, US FDA’s Center for Drug Evaluation & Research Director Janet Woodcock discusses her plans the Office of New Drugs, including changes to the structure of the office to make reviews better managed and more uniform across divisions. Woodcock says she expects to stay in the interim OND role for most of 2017.

FDA entrance sign 2016

US FDA’s Center for Drug Evaluation & Research Director Janet Woodcock, MD, will spend at least the next six months as acting head of the Office of New Drugs to implement policy and structural changes to the review process for new drugs and biologics.

Woodcock took over the office as acting director – rather than promoting someone from within the agency – after the previous director, John Jenkins, retired in January. (Also see "Jenkins' Retirement From US FDA Was Several Years In The Making" - Pink Sheet, 6 December, 2016.) She discussed her plans for changes in the office during a

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Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

 
• By Francesca Bruce

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.