Pharma



RESTRUCTURING SERVICES FOR U.S. PRESCRIBING INFORMATION

  • High quality, efficient and competitively priced.
  • A unique opportunity for Clients to reduce the time and resource burden of reformatting, and to build their own expertise by having their staff collaborate with our experts.
  • Providing complete project service as well as individual service elements.
  • Fast turnaround possible (approximately 48 hours for Phase I, see below), if planned ahead.
  • TASKS OF A TYPICAL RESTRUCTURING PROJECT

     

    Phase I - Creation of Draft Annotated FPI and Highlights Text Modules

  • Drafting of restructured, annotated FPI.
  • Drafting of Highlights text modules.
  • Preparation of Decision Support Checklist and special annotations for Client.
  • Telephone conference to walk the Client's labeling team through the drafts and explain specific decision making options.
  • Phase II - Client Review and Decision Making

     

    Phase III - Project Finalization

  • Finalization of annotated FPI and Highlights.
  • Creation of a non-annotated version of the restructured label tot serve as the basis for SPL conversion.
  • CREATION OF DRAFT ANNOTATED FPI AND HIGHLIGHTS TEXT MODULES

       Typical Deliverables:

  • Migration Table (MS Word table) showing which (sub)sections of the existing label have been migrated to which position in the new labeling structure.
  • 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 version).

     

    CREATION OF HIGHLIGHTS TEXT MODULES

       Typical Deliverables:

  • 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.

     

    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.

  • Comments in the HIGHLIGHTS Text Modules document.
  • 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.

     

    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. Clients should obtain a clean MS Word version of the completed reformatted draft label from their SPL service provider (either internal or external).

     

    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.