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Complying with the New Pregnancy and Lactation Labeling Rule PLLR Will You Be Ready Reviews by Experts Reviews Ready for Use By the Organization of Teratology Information Specialists OTIS

Our Experts Will Help You Streamline OTIS is here for you We provide expert consultation to pharmaceutical companies to produce the required comprehensive reviews of existing data and summaries of fetal and lactation risks for prescription medications OTIS Inc Board Our experts provide language that clearly conveys the data and will support labeling content Sarah G Obi an MD University of South Florida Morsani College of Medicine Why choose OTIS We ve been doing this a long time The Organization of Teratology Information Specialists OTIS is a professional scientific society OTIS is made up of teratologists experts on the effects of exposures during pregnancy and lactation Thorough literature reviews synthesis and translation of the data are all part of the OTIS communication process OTIS has been perfecting this process for more than 30 years connecting worldrenowned experts in the field of birth defects research with the general public The PLLR implementation has created an urgent need for current and comprehensive reviews of existing data and summaries of fetal and lactation risks Thousands of prescription medications fall under the PLLR timeline over the next five years an overwhelming task for many companies Our experts include world renowned teratologists members who already provide comprehensive evidence based reviews for groups like TERIS and Reprotox We translate data about medications in pregnancy and lactation for health care providers every day OTIS is a 501 c 3 nonprofit organization and has established a national call routing system Since 2002 anyone in North America calling the toll free number 1 866 626 6847 has been routed to an affiliated service to speak with an expert This service network was later renamed MotherToBaby and has evolved into communicating exposure risks to the public through a variety of innovative ways that include written fact sheets online articles by telephone live web chat and texting Stephen R Braddock MD OTIS President Melissa S Tassinari PhD retired Sr Clinical Advisor US Food and Drug Administration Katherine L Wisner MD MS Northwestern University Feinberg School of Medicine Christina D Chambers PhD MPH OTIS President Elect Ex Officio Member Advisory Board Philip O Anderson Pharm D Author of LactMed database Gerald G Briggs B Pharm FCCP Co Author of Drugs in Pregnancy and Lactation Cheryl S Broussard PhD Centers for Disease Control and Prevention NCBDDD Alicia B Forinash Pharm D FCCP BCPS BCACP Co Author of Drugs in Pregnancy and Lactation Jan M Friedman MD PhD TERIS Principal Investigator Janine E Polifka PhD TERIS Project Director Anthony R Scialli MD Reprotox Director Collaborating with OTIS Will Make the PLLR Update Process Easy for You Advisory Board The Advisory Board was established to develop and initiate the safety literature review program for use in PLLR labeling EXHAUSTIVE LITERATURE SEARCH CRITICAL SUMMARY EXPERT REVIEW REPORT

Our Experts Will Help You Streamline OTIS is here for you We provide expert consultation to pharmaceutical companies to produce the required comprehensive reviews of existing data and summaries of fetal and lactation risks for prescription medications OTIS Inc Board Our experts provide language that clearly conveys the data and will support labeling content Sarah G Obi an MD University of South Florida Morsani College of Medicine Why choose OTIS We ve been doing this a long time The Organization of Teratology Information Specialists OTIS is a professional scientific society OTIS is made up of teratologists experts on the effects of exposures during pregnancy and lactation Thorough literature reviews synthesis and translation of the data are all part of the OTIS communication process OTIS has been perfecting this process for more than 30 years connecting worldrenowned experts in the field of birth defects research with the general public The PLLR implementation has created an urgent need for current and comprehensive reviews of existing data and summaries of fetal and lactation risks Thousands of prescription medications fall under the PLLR timeline over the next five years an overwhelming task for many companies Our experts include world renowned teratologists members who already provide comprehensive evidence based reviews for groups like TERIS and Reprotox We translate data about medications in pregnancy and lactation for health care providers every day OTIS is a 501 c 3 nonprofit organization and has established a national call routing system Since 2002 anyone in North America calling the toll free number 1 866 626 6847 has been routed to an affiliated service to speak with an expert This service network was later renamed MotherToBaby and has evolved into communicating exposure risks to the public through a variety of innovative ways that include written fact sheets online articles by telephone live web chat and texting Stephen R Braddock MD OTIS President Melissa S Tassinari PhD retired Sr Clinical Advisor US Food and Drug Administration Katherine L Wisner MD MS Northwestern University Feinberg School of Medicine Christina D Chambers PhD MPH OTIS President Elect Ex Officio Member Advisory Board Philip O Anderson Pharm D Author of LactMed database Gerald G Briggs B Pharm FCCP Co Author of Drugs in Pregnancy and Lactation Cheryl S Broussard PhD Centers for Disease Control and Prevention NCBDDD Alicia B Forinash Pharm D FCCP BCPS BCACP Co Author of Drugs in Pregnancy and Lactation Jan M Friedman MD PhD TERIS Principal Investigator Janine E Polifka PhD TERIS Project Director Anthony R Scialli MD Reprotox Director Collaborating with OTIS Will Make the PLLR Update Process Easy for You Advisory Board The Advisory Board was established to develop and initiate the safety literature review program for use in PLLR labeling EXHAUSTIVE LITERATURE SEARCH CRITICAL SUMMARY EXPERT REVIEW REPORT

Take Advantage of Our Unique Expertise and Experience to Meet Your Deadlines OTIS has been providing evidence based medication risk assessments during pregnancy and lactation for more than 30 years Capitalizing on this experience will save you time and help streamline Pregnancy and Lactation Labeling Rule compliance Contact info Organization of Teratology Information Specialists OTIS Attn PLLR 5034A Thoroughbred Lane Brentwood TN 37027 615 649 3082 contactus otispregnancy org For more information please visit www MotherToBaby org OTISInc OTIS Inc is a wholly owned Benefit Corporation of the Organization of Teratology Information Specialists