Data Information Outcomes

A variety of types of information are produced by the R&D organization as outcomes, including labeling for the product (package insert), extensions to the labeling often for expanded indications, regulatory applications for product approvals or expanded product information, presentations at scientific meetings, publications of the studies conducted, and educational materials, to be discussed below.

First, as part of the new product application to regulatory authorities, the company writes the draft of the official package insert (PI). The PI is tightly controlled by regulators in its organization and content (12 standard sections), as described in this next figure (Fig. 3.17). The PI must use these terms for subheads and follow this order of information. The label is reviewed in detail and approved by the regulators, but much negotiation between the company and the regulatory authorities occurs because the company wants accuracy and completeness but as much flexibility as possible in wording. The PI gives the clinician background information and usage information to guide its prescribing and monitoring for efficacy and side effects. The words in the PI for the business are the limits of any advertisement or sales person activity, and a competitive edge versus other products is highly desirable if the clinical data supports the statements, which the regulators demand of course. The importance of the PI content is critical for patient care and business opportunity.

A second labeling outcome is an expansion of the labeling by the company and/or required by the regulatory authorities (Fig. 3.18). The company will perform a great deal more research after the product is approved and marketed to obtain approval for a new indication, or expanding usage and marketing activity, or offer more safety information. For existing indications, new clinical research may demonstrate additional dosing approaches, new administration techniques, special subpopulations that may respond better or worse to the product, and perhaps added quality of life benefits for the patients and health care systems. New studies may require new safety precautions as we learn more about the product. With the much broader use of a product postmarketing, more side effects or more severe manifestations of listed side effects may arise, all requiring labeling changes to better guide the clinicians in using this product more appropriately. The majority of pharmacoeconomic studies is done after a product is marketed, which may yield information for labeling, such as quality of life improvements (QOL) [44].

Regulatory applications will discussed in full in Chapter 7, and the many types are listed here (Fig. 3.19) as another informational and data outcome from a company. The NDA, BLA and PLA are an exceptionally complete set of documents to establish safety and efficacy of the product, along with manu-

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