How to Write Clear and Concise Reviews - A Plain Writing Workshop

CBER requires the services of a commercial vendor to deliver a tailored off-the-shelf, technical writing course that teaches staff how to write clear and concise technical documents using Plain Language and is tailored to include examples of effectively writing deficiencies to manufacturers using four-part harmony to improve the manufacturer's comprehension of FDA's analysis of the review. CBER requires both initial and refresher classroom training for CBER personnel. The classroom training will help ensure CBER personnel provide clear and concise reviews of deficiencies when writing reports on manufacturer submissions. The course will need to be provided to the CBER population in the following number of iterations;
Base Year - 12 Initial Sessions and No Refresher Sessions
Option Year 1 - 4 Initial Sessions and 8 Refresher Sessions
Option Year 2 - 5 Initial Sessions and 7 Refresher Sessions
Four-Part Harmony is defined as a four-step process that provides the recipient of the deficiency letter with a clear and complete request. The steps are 1) What they provided; 2) What is deficient; 3) What we want; and 4) Why we want it. This consistent method of notifying manufacturers of a deficiency within their application package ensures consistency between FDA Centers and revieweres in how deficiencies meet the requirements outlined in the FDA Reauthorization Act of 2017..