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# FDA Looks to Technology Advances to Help Product Labeling
- URL: https://www.fdaweb.com/fda-looks-to-technology-advances-to-help-product-labeling/
- Published: 2018-10-17T12:00:00.000Z
- Updated: 2026-09-15T00:38:46.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5142609

FDA is evolving to keep pace with technology advances, and one area it wants to focus on is product labeling and new resources and approaches to “appropriately incorporate additional clinically important information into product labeling,” FDA chief of staff **Lauren Silvis** 10/17 told a Food and Drug Law Institute advertising and promotion conference in Washington, DC. As an example, she offered the ongoing opioid crisis and the needed changes to labeling to reduce unnecessary or excessive exposure to opioids.

“Evidence-based prescribing guidelines can help providers determine the appropriate duration of use for opioid analgesics for a given indication,” Silvis said. “That’s why we’re working with medical practice societies to arm health care providers with the most current and comprehensive guidance on appropriate pain management by developing a framework for creating evidence-based guidelines on appropriate opioid analgesic prescribing.”

FDA has also contracted with the National Academies of Sciences, Engineering, and Medicine to conduct a consensus study and report that will help advance evidence-based guidelines for appropriate opioid-analgesic prescribing, according to Silvis. “This work will help us understand what evidence is needed to ensure that current and future clinical practice guidelines for opioid-analgesic prescribing minimize the risk of addiction and abuse, and what research is still needed to generate that evidence in a practical and feasible manner,” she said.

Another example of how FDA is looking to modernize product labeling involves antimicrobial resistance (AMR). The agency has a [Web site](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588836.htm?ref=fdaweb.com) that updates FDA breakpoints information, which helps physicians determine whether a specific bacteria or fungi are susceptible to antibacterial or antifungal drugs. “FDA has issued guidance explaining drug manufacturers’ obligation to update their labeling by December of this year to include a reference to the FDA breakpoints Web site,” Silvis told FDLI. “This will relieve sponsors from having to continuously update their labeling with new breakpoint information. The process of communicating breakpoint information will be more efficient — and we’ll have a reliable reference in the labeling to the most up-to-date information needed by healthcare professionals and patients.”

Additionally, FDA is employing novel approaches to help product review and labeling keep pace with scientific advances, such as next-generation sequencing (NGS), which can detect tens of thousands of gene or protein variants in a single test, Silvis said. “To support innovation in NGS testing, FDA developed an approach focused on leveraging publicly available databases to support claims of clinical validity,” she said. “One potential example of such a consensus database would be the NIH’s ClinGen, which works to standardize the clinical annotation and interpretation of genomic variants through evidence-based expert consensus.”

  
Eventually, Silvis said FDA will encourage “expert-based crowd sourcing of NGS evidence generation, curating, and data sharing – which can all advance the development of high quality precision medicine treatments and diagnostics, with validated new information used to update medical product labeling through an agile scientific process.”