Literature Reviews

Sanova’s literature reviews capture information from scientific papers, studies, journal articles, and sometimes, white papers and posters (“sources”) on a particular product category, such as snus, heated tobacco products or nicotine pouches. The Sanova lead, subject matter experts and a team of scientific reviewers and writers screen source abstracts and full-texts for inclusion and summarize the relevant data to provide a brief but accurate and thoughtful presentation of the salient points of the sources. The review seeks to synthesize and evaluate the concepts and results to best represent the state of the science for a given research focus. The approach is grounded in scientific evidence and neutral evaluation of the articles.

To conduct a comprehensive literature review, every aspect of the process requires careful attention. The definition of the research focus must be carefully described so as not to be too narrow nor too large in scope. The searches, depending on the relevant date range, might include hundreds if not thousands of sources for screening. Even after reviewing against inclusion and exclusion criteria, there typically still is an extensive set of scholarly sources to review. The process of accurately summarizing those sources into a narrative document and into tables is time consuming. Each abstract and full text source is reviewed by two independent reviewers, at a minimum, to ensure information is captured correctly and in an unbiased manner. Writing narratives synethesizing these scientific sources is time consuming and also requires multiple reviews to ensure accuracy. The final work product is subject to additional quality checks and editing.

We facilitate cost sharing. We believe that many businesses need literature reviews and the costs of the literature reviews can be shared among them, making science more available and affordable. With Sanova’s cost share option, we spread the cost among participating clients, so no one client has to bear the total cost. Once participation rates exceed four clients, we charge everyone the same flat fee for the literature review. We estimate the costs of foundational and annual reviews each year and discuss costs and cost sharing with participating and interested clients in advance of undertaking any review. We also offer access to existing literature reviews to interested businesses at a set cost share price. We use our own TPMFs. Sanova’s approach to literature reviews is unique in that we publish our results via a Tobacco Master Product File (“TPMF”). Our participating clients then receive a Letter of Authorization (“LOA”) to reference the Sanova TPMF in regulatory filings to substantiate regulatory and scientific positions and conclusions, such as in a PMTA. Rather than continually updating or amending regulatory filings, Sanova updates its TPMF and participating clients receive access to the additional materials through an updated LOA. In addition to providing participating clients with a LOA to access our TPMF, we also provide full copies of the review and the articles for internal use to support general regulatory, quality and product development functions. We conduct foundational and annual reviews. Sanova’s existing TMPFs include literature reviews for several major product categories. We update those reviews annually and include the updates in our existing TPMFs. Existing foundational and annual updates are available for purchase on our cost share basis. A foundational review in a product category is usually the most expensive undertaking, with annual reviews often being less expensive. A foundational review defines a time period for a product category from relevant inception date through a current date. The philosophy is to set the baseline understanding of relevant literature for that product category. Once the foundational review is complete, Sanova then updates it annually to ensure that the review continues to reflect the state of the science. Often annual reviews are less expensive because the number of articles to review declines over time. However, that is not always the case. A novel product category may take time to gain focus in the scientific literature, making subsequent reviews costly because of an increase in the number of relevant sources.

The Tobacco Control Act (“TCA”) and its implementing regulations require literature reviews be included in a Premarket Tobacco Product Application (“PMTA”). See 21 CFR §1114.7(k)(2)(requiring a literature search for each type of information in 21 CFR §1147(k)(1) which includes 1) health risks of the product, 2) impacts on tobacco use behavior of tobacco product users, 3) impacts on tobacco use initiation by nonusers, including youth, young adults and other relevant vulnerable populations, and 4) human factors). Literature reviews can also assist in providing critical scientific evidence that may not be available or may be cost or time prohibitive, in which case literature reviews with appropriate bridging may provide a sufficient scientific foundation for the FDA to evaluate the product. Literature reviews can also be important components of Modified Risk Tobacco Product Applications (“MRPTAs”) and Investigational Tobacco Products Applications (“ITPs”). Postmarket surveillance is also required by the TCA and its implementing regulations for all products receiving marketing granted orders (“MGOs”) through the PMTA pathway. All applicants receiving a MGO must conduct postmarket surveillance and submit periodic reports for the life of the MGO. These reports must include, “[f]ull reports of information published or known to, or which should be reasonably known to, the applicant concerning scientific investigations and literature about the tobacco product that have not been previously reported, including significant findings from publications not previously reported.” 21 CFR §1114.41(a)(1)(iv). See also 21 CFR §1114.41 (a)(1)(iii), (a)(1)(vii) and (xi) (requiring summaries of ongoing studies, formative consumer research studies and summaries of consumer evaluation research studies). Sanova’s foundational and annual literature reviews are a critical part of the application process for a tobacco product as well as postmarket compliance following MGO and can be done more cost effectively through Sanova’s cost share program.