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Pink Sheet – 'Just Say It!' – New Streamlined Guidance Format Coming, FDA's Woodcock Says

Pink Sheet – 'Just Say It!' – New Streamlined Guidance Format Coming, FDA's Woodcock Says

Executive Summary

US guidances will be shorter and use a series of bullet points to communicate key ideas, replacing the current longer and wordier format.

FDA is embracing the short bulleted list to communicate its thinking about drug development going forward.


Rather than continue issuing guidances that are riddled with legalese, long paragraphs and sometimes extensive footnotes, going forward the documents will be shortened to a few pages containing just the major points the agency wants to get across.


Center for Drug Evaluation and Research Director Janet Woodcock said Nov. 14 that the new format should appear soon and will be particularly useful for upcoming disease-focused drug development guidances.


Woodcock said guidances as written now are not clear enough.


“Just say it,” she said describing the new guidance layout following a panel discussion at the Biopharma Congress, sponsored by Prevision Policy and the Friends of Cancer Research. “We’re trying to give the basic bottom line.”

Janet Woodcock

Woodcock said new guidances will include information such as what endpoints or patient exposure that the agency will accept, but no longer include “prose” and extraneous language. She said they will “just encapsulate what the policy points that we wish to relay to the community are.”


That means that a 15-page guidance could be shortened to two pages.


Such a change would be a significant shift in how FDA communicates its thinking to drug sponsors, stakeholders and the public at large. Often, new guidances actually lead to confusion or misinterpretation of the agency’s intent.


Woodcock said during the panel discussion that the goal is “streamlined message development that we can get out quickly so that we begin to have an up-to-date … set of standards for different disease areas about what the development path is supposed to look like.”


FDA Commissioner Scott Gottlieb has said that the agency plans to release 10 disease-focused guidances soon, including five covering neurological diseases. (Also see “Q&A With US FDA Commissioner Scott Gottlieb” – Pink Sheet, 9 Nov, 2017.) Among those guidance topics will be Alzheimer’s disease. (Also see “Alzheimer’s Guidance Coming From US FDA, Part Of Broader OND Reform” – Pink Sheet, 14 Sep, 2017.)


The guidance change is part of FDA’s research into restructuring the Office of New Drugs. Woodcock, OND’s temporary leader, initiated the discussion following the departure of long-time director John Jenkins. (Also see “Jenkins’ Retirement From US FDA Was Several Years In The Making” – Pink Sheet, 6 Dec, 2016.)


The current division staffing set-up is under review, including whether reviewers can be grouped to move between divisions depending on workload. (Also see “CDER Director Woodcock Plans Changes To Drug Reviews During OND Transition” – Pink Sheet, 6 Mar, 2017.)


The agency also is considering creating a single shared OND review memo to make the information more accessible. (Also see “Gottlieb Promotes ‘Team’ Work For Product Reviews” – Pink Sheet, 3 Nov, 2017.)

When Will We See New Format?

It is unclear when the newly formatted guidances will begin appearing publicly.


Woodcock said many currently are undergoing agency clearance. She said she plans a stream of guidances under the new format.


“Some of the ones that come out probably won’t be so bulleted as I’d like because they were started beforehand,” she said.


The new format should become familiar in the coming months.


FDA is required to produce many guidances under both the 2017 FDA Reauthorization Act and 2016 21st Century Cures Act, including how FDARA’s new competitive generic therapy designation will function. (Also see “New ANDA Review Pathways: Should You Be A Priority Or Expedited?” – Pink Sheet, 13 Nov, 2017.)

Will Fewer Pages Mean Less Confusion?

The new format suggests a view that brevity reduces ambiguity. Still to be seen is whether it sometimes causes confusion as well, with sponsors requesting more information or clarification.


Woodcock added after the panel discussion that sponsors can ask the relevant review division if they questions about the guidances.


The minimalist approach also could drive more requests for in-person meetings or teleconferences with FDA staff; such meetings are resource intensive for scheduling and preparation, as well as after completion. (Also see “US FDA Commits To Meeting With Complex ANDA Sponsors, Works Hard To Avoid It” – Pink Sheet, 24 Oct, 2017.)


Interestingly, the agency is implementing format changes similar to ones it recommended years ago for drug labels. (Also see “Warning Label Final Guidance Recommends Use Of Numeric Adverse Reaction Rates” – Pink Sheet, 12 Oct, 2011.)–New-S…