FDA Guidance Going on a Diet


FDA guidance documents always stress they don’t give anybody any rights and don’t bind the agency to anything they say—instead, they merely represent the agency’s “current thinking” on a topic.

On the documents themselves, Janet Woodcock’s current thinking is that they’re too clunky. Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said the agency plans to tighten them up, at least for those addressing drug development for specific diseases.

“We’re going to try to not have our guidance documents be so long and not in prose but just encapsulate what the policy points that we wish to relay to the community are,” Woodcock mentioned during a panel discussion at this year’s Biopharma Congress, an event put on by Prevision Policy and Friends of Cancer Research.

She’s thinking bullet points, not dense text. And shorter explanations—two-pagers are possible, Woodcock told reporters after her appearance.

“What we’re trying to give them is the basic, bottom-line, salient points,” she said.

New guidance documents following this format are in the pipeline and undergoing internal review now, Woodcock said, although some already cleared to go out will largely follow the traditional format.

Woodcock wants to get a “stream” of concise guidance documents out that update current ones that are obsolete.

“It’s really sort of a streamlined message development that we can get out quickly so that we can have up-to-date standards for different disease areas,” she said.

New guidance documents will provide the basics, Woodcock said—what a development path should look like, what the end points should be, how many participants to include, for example.

The approach will be figuring out “what to tell them and just say it,” she said. “So that’s what we’re going to try to do. We’ll see.”

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