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  1. Development Resources

Division of Pediatric and Maternal Health - Publications

  • Freeman MP, Farchione T, Yao L, Sahin L, Taylor L, Huybrechts K, Nonacs R, Sosinsky A, Viguera AC, Cohen LS. Psychiatric Medications and Reproductive Safety: Scientific and Clinical Perspectives Pertaining to the US FDA Pregnancy and Lactation Labeling Rule. J Clinical Psychiatry 79:4, July/August 2018.
  • Bird ST, Gelperin K, Taylor L, Sahin L, Hammad H, Andrade SE, Mohamoud MA, Toh S, Hampp C. Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer's Capture of Spontaneous Reports for Exposed Pregnancies. Drug Saf. 2018 Jan; 41(1):87-94.
  • Teratology Society Teratology Primer 3rd Edition, 2018 1. What Are the Ethical and Scientific Considerations for the Inclusion of Pregnant and Breastfeeding Women in Clinical Trials? 2. Pregnancy and Lactation Labeling. Sahin L, Marie Teil,
  • Gelperin K, Hammad H, Leishear K, Bird S, Taylor L, Hampp C, Sahin L. A systematic review of pregnancy exposure registries: examination of protocol-specific pregnancy outcomes, target sample size, and comparator selection. Pharmacoepidemiology and Drug Safety 2017 Feb; 26 (2):208-214.
  • Wang J, Johnson T, Sahin L, Tassinari MS, Anderson PO, Baker TE, Bucci-Rechtweg C, Burckart GJ, Chambers CD, Hale TW, Johnson-Lyles D, Nelson RM, Nguyen C, Pica-Branco D, Ren Z, Sachs H, Sauberan J, Zajicek A, Ito S, Yao LP. Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary. Clin Pharmacol Ther. 2017 Jun;101 (6):736-744.
  • Dinatale M, Sahin L, Johnson T, Howard T, Yao L. Medication Use During Pregnancy and Lactation: Introducing the Pregnancy and Lactation Labeling Rule. Pediatric Allergy, Immunology, and Pulmonology. June 2017, Vol. 30, No. 2: 132-134.
  • Andrade SE, Reichman ME, Mott K, Pitts M, Kieswetter C, Dinatale M, Stone MB, Popvic J, Haffenreffer K, Toh S. Use of selective serotonin reuptake inhibitors (SSRIs) in women delivering liveborn infants and other women of child-bearing age within the U.S. Food and Drug Administration’s Mini-Sentinel program. Arch Womens Ment Health. 2016; 19(6): 969-977.
  • Sahin L, Nallani SC, Tassinari MS. Medication use in pregnancy and the pregnancy and lactation labeling rule. Clin Pharmacol Ther. 2016. Jul;100(1):23-5.
  • Hansen C, Andrade SE, Freiman H, Dublin S, Haffenreffer K, Cooper WO, Cheetham TC, Toh S, Li DK, Raebel MA, Kuntz JL, Perrin N, Rosales AG, Carter S, Pawloski PA, Maloney EM, Graham DJ, Sahin L, Scott PE, Yap J, Davis R. Trimethoprim-sulfonamide use during the first trimester of pregnancy and the risk of congenital anomalies. Pharmacoepidemiol Drug Saf. 2016 Feb; 25(2):170-8.
  • Sahin L. The FDA Perspective on the Ethical Barriers of Conducting Research in Pregnant Women. American Journal of Bioethics Primary Research, 2(1):13-14, 2011.
  • Goldkind S, Sahin L, Gallauresi B. Enrolling pregnant women in research- Lessons from the H1N1 influenza pandemic. N Engl J Med 2010; 362:2241-3.
  • Best Pharmaceuticals for Children Act (BPCA) BPCA provides an incentive of additional marketing exclusivity to sponsors who voluntarily complete pediatric clinical studies outlined in a Written Request issued by FDA.
  • Written Requests Issued
    List of approved active moieties and the sponsor to whom the written request was issued.
  • Pediatric Formulations Developed to Earn Pediatric Exclusivity But Not Marketed (PDF - 19 KB)
  • Pediatric Formulations Unable to be Developed
  • Pediatric Research Equity Act (PREA) PREA gives FDA the authority to require pediatric studies in certain drugs and biological products. Studies must use appropriate formulations for each age group. The goal of the studies is to obtain pediatric labeling for the product.
  • Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
    Fulfills requirement that FDA post the PREA Non-Compliance letter and sponsor’s response.
  • Pediatric Study Plan Template (PDF - 25 KB)
  • Postmarket Requirements and Commitments Database
    To view PREA postmarket requirements, check the Pediatric Research Equity Act box in the 'Required Under' section.
  • Automatic Full Waivers (PDF - 26 KB)
    List of diseases for which FDA automatically grants a full waiver of pediatric studies.
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