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# Woodcock Praises Generic Drug Program Transformation
- URL: https://www.fdaweb.com/woodcock-praises-generic-drug-program-transformation/
- Published: 2016-01-21T12:00:00.000Z
- Updated: 2026-09-15T02:29:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134508

> CDER director **Janet Woodcock** says that the successful transformation of the Center’s generic drug program and moving it to a very high level of productivity was CDER’s top success in 2015\. Speaking in a Director’s Corner [podcast](http://www.fda.gov/Drugs/NewsEvents/ucm431929.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), she said the changes involved a new information technology platform and transforming the generic drug process to a modern process. Other successes she cited were the start-up of the Office of Pharmaceutical Quality and the approval of the first biosimilar product in the U.S.  
>  
> Asked about some of the year’s challenges, Woodcock referenced the congressional push for the 21st Century Cures legislation in the House, and hiring enough people to be able to do all the work facing the Center.  
>  
> Goals for 2016, she said, include completing the various user fee reauthorization negotiations, OTC monograph reform, determining how to regulate commercial speech in light of recent First Amendment court decisions, what additional steps FDA can take to address the prescription opioid epidemic, and staff hiring and leadership development.  
>  
> “If I could have 800 people on board this very minute who aren’t here right now, I think we’d all be in a much better position to get all this done in the next year,” Woodcock said. “But unfortunately this is going to require a huge amount of work on many folks’ part in the Center and the agency to get the staff we need on board to get all this work done.”