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# Breakthrough Drugs Get More FDA Input: Woodcock
- URL: https://www.fdaweb.com/breakthrough-drugs-get-more-fda-input-woodcock/
- Published: 2018-05-09T12:00:00.000Z
- Updated: 2026-09-15T00:03:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141397

CDER director **Janet Woodcock** says that when a drug candidate qualifies for breakthrough therapy designation, sponsors can get greater input from FDA staff so that development can move along as efficiently as possible. Speaking on a CDER Director’s Corner [podcast](https://www.fda.gov/Drugs/NewsEvents/ucm431929.htm?ref=fdaweb.com), Woodcock emphasized that the designation does not signal a lowering of the approval standard.

“Basically, they get more attention,” she says. “Senior management and others get directly involved to advise on what the further clinical development program trial should look like, guide the process, and ensure that across all the involved disciplines, there is efficiency, and we try to move things along. So we can advise sponsors on what analyses to do, study size, methodology, and different other components…. When you see something like this, you really want to get all hands on deck and everybody help move this through.”

She stressed that there are times when the evaluation of a breakthrough drug doesn’t work out and the designation can be withdrawn if need be.

“It doesn’t mean that everything that looks promising when it’s further evaluated is actually going to be a significant advance,” she said. “But we feel that if it looks promising, we owe it to the patients, we ought to move this along, get it evaluated and see whether or not it is a big advance,”

Woodcock reviewed the criteria FDA applies in determining whether to grant a breakthrough designation and noted that for a drug candidate to get this status, it does not have to be curative or perhaps even dramatically better than existing therapies, but it does have to be substantially better.