US PI Restructuring
The following is a general description of the restructuring process.
Phase I:
Creation of Draft Annotated FPI and Highlights Text Modules
Creation of Restructured Full Prescribing Information
Typical Deliverables:
- Migration Table (MS Word table) showing which (sub)sections and elements of the existing label have been migrated to which position in the new labeling structure. An essential QC tool for the Client and for FDA: allows easy verification that no piece of the original label has been lost.
- Annotated Draft FPI (MS Word) containing restructured FPI in two-column format with
- Annotations for FDA and
- Temporary comments to help Client in decision-making (removed in final ver sion).
Creation of Highlights Text Modules
Typical Deliverable:
- Highlights Text Modules ("bullet points") presented in FDA's MS Word template.
- Serves as "pick-list" for the Client when deciding which information to elevate to Highlights and as a starting point for further editing.
- Presentation in FDA template shows actual size vis-à-vis the half page standard.
- Review against Annotated Draft FPI is greatly facilitated by color mark-up in FPI text of all content that is reflected in the Highlights pick-list.
Our Text Migration, Writing and Commenting Policy
While providing extensive support for decision making, it is our policy to not limit a Client in making decisions on the placement of information (e.g. elevating information to the WARNINGS and PRECAUTIONS section, or to HIGHLIGHTS).
Text Migration
As far as feasible, emphasis given to information by prominent placement is retained (e.g. retaining the relative order of subsections of the former WARNINGS section). Whenever there are several placement options, text is moved to its "baseline" section in the new format. Example: Population subset information (e.g. "on patients with renal impairment" from the former PRECAUTIONS section is moved to the USE IN SPECIFIC POPULATIONS section).
In such cases, it is left to the Client to decide whether information deserves to be placed or repeated in a higher-level section, or whether the sequence of subsections needs to be changed.
Writing and Commenting
When drafting text (e.g. to create transitions between paragraphs, or when creating HIGHLIGHTS text modules), we pay attention to stay within the limits of existing labeling content and emphasis, and not to lose nuances of meaning. Example: "Should not" wording in FPI is not converted to "do not" wording in HIGHLIGHTS modules. Our comments are written in a neutral manner, pointing to decision options rather than recommending a specific solution.
Phase II:
Client Review and Decision Making
The Client’s decision making on final format and content is supported by:
- Comments in the Annotated Draft FPI
- Comments in the Highlights Text Modules document
- Providing a Decision-Support Checklist*, partially completed and with comments
- Walk through of important label-specific points to consider by one of our Subject Matter Experts, informing the Client in more detail about certain decision options (discussion typically by phone )
* For each check-point, the Decision-Support Checklist contains convenient full-text citations of CFR 201.56 / 201.57 and FDA's (draft) guidance documents for quick lookup of FDA's expectations plus, if necessary, pointers to approved U.S. labeling that illustrates certain requirements and guidelines.
Based on the materials provided by Pharmiceutics and additional information received during the direct discussion of points to consider with one of our experts, the Client makes all decisions necessary for finalization of the reformatted label.
Our decision support helps the Client to focus on relevant issues and is intended to significantly increase efficiency of decision making. Our Decision-Support Checklist puts relevant background information at the Client's fingertips.
Phase III:
Project Finalization
After having received the Client's decisions, we finalize the FPI and Highlights section.
The previously provided Migration Table, Annotated Draft FPI and Highlights are updated and combined into a single, submission-ready document, providing FDA with a fully annotated "restructuring roadmap". The Client can use this annotated document to incorporate additional labeling changes with further annotations.
Typical Deliverables:
- Submission-Ready Document (MS Word document) with Migration Table and annotated prescribing information (Highlights and restructured FPI); quality controlled and submission ready.
- Annotation-free version of the restructured PI that indicates text considered to represent recent major changes (MS Word document). This document is prepared for the SPL conversion provider and not intended for submission to FDA.
Clean MS Word version of the reformatted label: Clients should obtain a clean MS Word back-conversion of the completed reformatted draft label from their SPL service provider (possibly the most economical solution). As an alternative, Pharmiceutics can provide a submission-ready, clean MS Word version.
If You Need More
We are available for: Consultation during decision making. Drafting new text (e.g. patient counseling information) or making major modifications to existing content/text.