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RESTRUCTURING SERVICES FOR U.S. PRESCRIBING INFORMATION |
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TASKS OF A TYPICAL RESTRUCTURING PROJECT |
Phase I - Creation of Draft Annotated FPI and Highlights Text Modules
Phase II - Client Review and Decision Making
Phase III - Project Finalization
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CREATION OF DRAFT ANNOTATED FPI AND HIGHLIGHTS TEXT MODULES |
Typical Deliverables:
- Annotations for FDA and
- Temporary comments to help Client in decision-making (removed in final version).
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CREATION OF HIGHLIGHTS TEXT MODULES |
Typical Deliverables:
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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).
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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.
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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.
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CLIENT REVIEW AND DECISION MAKING |
The Client’s decision making on final format and content is supported by providing:
Comments in the Annotated Draft FPI.
* 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.
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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.
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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. Clients should obtain a clean MS Word version of the completed reformatted draft label from their SPL service provider (either internal or external).
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IF YOU NEED MORE |
We are available for: