The FDA Pregnancy and Lactation Labeling Rule (PLLR) requires the revision of product labeling for all drugs approved after June 2001. This is a huge volume of work for the pharmaceutical companies that must be completed by 2020. OTIS is here for you. OTIS, Inc. is a wholly owned Benefit Corporation of the Organization of Teratology Information Specialists and our experts provide consultation to pharmaceutical companies to produce the required comprehensive reviews of existing data and summaries of fetal and lactation risks for prescription medications. Our experts provide language that clearly conveys the data and will support labeling content. Interested? Contact us for a quote: contactus@otispregnancy.org and review our digital service brochure. Click below: