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Therapeutic Innovation & Regulatory Science|December 17, 2023
Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape AssessmentAmalia Alexe, Anju Garg, Birgit Kovacs, et al.British Journal of Clinical Pharmacology|October 4, 2023
Call to action: Harmonization of pharmacovigilance regulations for post-marketing pregnancy and breastfeeding safety studiesAmalia Alexe, Osa Eisele, Maria Fernanda Scantamburlo Fernandes, et al.Journal of Pregnancy|January 22, 2024
Drug Utilization Studies in Pregnant Women for Newly Licensed Medicinal Products: A Contribution from IMI ConcePTIONSandra Lopez-Leon, Anja Geldhof, Julie Scotto, et al.Therapeutic Innovation & Regulatory Science|March 17, 2025
Post-approval Activities Providing Data on the Safety of Medication Use During Pregnancy and Lactation-A TransCelerate PerspectiveMaria Fernanda Scantamburlo Fernandes, Amalia Alexe, Olatayo Apara, et al.Birth Defects Research|September 30, 2022
Belimumab use during pregnancy: Interim results of the belimumab pregnancy registryPatricia Juliao, Keele Wurst, Jeanne M Pimenta, et al.Annals of the Rheumatic Diseases|October 5, 2022
Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reportsMichelle Petri, Helain Landy, Megan E B Clowse, et al.Pageof 2