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Title: Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products. Author: Tassinari MS, Sahin L, Yao LP. Journal: Birth Defects Res A Clin Mol Teratol; 2015 Aug; 103(8):718-20. PubMed ID: 26223007. Abstract: BACKGROUND: Obtaining human pregnancy data to inform product labeling is important for drug and biological products. METHODS: Collection and analyses of safety data on their use during pregnancy is usually performed after approval. RESULTS: The Centers for Disease Control National Birth Defects Prevention Study has provided important data on the relationship between drug use in pregnancy and birth defects. CONCLUSION: The Pregnancy and Lactation Labeling Rule will set new and improved standards for the inclusion of information about the use of prescription drugs and biological products during pregnancy; the National Birth Defects Prevention Study, along with other data sources, will be critical for providing safety data to inform product labeling.[Abstract] [Full Text] [Related] [New Search]