US FDA Blood Pressure Risk Assessment Guidance Uses Unique Format

As agency embraces bullet-point format, old-school draft full of call-outs and solicitations seems unlike anything before or since. Regardless of style, FDA's testing recommendations for developmental therapies are of broad, substantive interest to industry.

Hand points to business flow chart

Center for Drug Evaluation & Research Director Janet Woodcock believes that the US FDA has figured out how to get guidances out much more rapidly, touting a “just-say-it” approach that focuses on bullet points and key messages rather than longer, discursive text. (Also see "'Just Say It!' – New Streamlined Guidance Format Coming, FDA's Woodcock Says" - Pink Sheet, 14 November, 2017.)

During the recent Food & Drug Law Institute annual meeting, in fact, Woodcock responded to a question about what is...

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